Let's try this again!

This info is public record. It is an excerpt taken directly from DHHS's website:

www.fda.gov/MedicalDevices/Safety/ReportaProblem/EventProblemCodes/ucm134761.htm


REPORT YOUR CRAP, I MEAN LAP-BAND PROBLEMS DIRECTLY TO THE FDA!!!

 

But you, the consumer, have the right to report the problems directly to the FDA!  Here’s where you do it: https://www.accessdata.fda.gov/scripts/medwatch/

 

They want you to use specific codes, selected from a HUGE list of arcane descriptions (http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/Even tProblemCodes/ucm134761.htm).  Here are a few suggested ones you might find helpful:

 

Device Operational Issue - LEVEL 1 - Issue associated with any deviations from specifications relating to device operations (e.g. deployment, connection, electrical, computer software, infusion/flow, output, protective measure, and incompatibility issues).

 

Device Operates Differently than Expected C62955; FDA 2913 - Issue associated with any deviations from expected performance while operating and using the device.

Therapy delivered to incorrect body area C62858; FDA 1508 - Issue associated with the device causing unintended therapeutic action to an area of the body other than the intended area.

Calibration Issue C63028; FDA 2890 - Issue associated with the operation of the device, related to its accuracy, and associated with the calibration of the device

 

Connection Issue C62952; FDA 2900 - Issue associated with linking of device and/or device components and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data.

Blocked Connection C63288; FDA 2888 - Issue associated with linking of device and/or device components whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded.

Filling Problem C63144; FDA 1233 - Issue associated with the method or amount of time associated with the delivery of a fluid. Time to delivery or amount of delivered entity may be affected.

• Inability to Auto-fill C63106; FDA 1044
• Overfill C62884; FDA 2404
• Short Fill C62841; FDA 1575
• Volume Accuracy Issue C62805; FDA 1675

Inflation Issue C63076; FDA 1310 - Issue associated with the inability of a device and/or device components to expand or enlarge with the intended inflation agent (e.g. saline or air)

Occlusion within Device C62896; FDA 1423 - Issue associated with an obstruction or blockage within any of the device components (e.g. tube, opening, pipe) that results in a restriction of flow.

 

Human Factors Issue - LEVEL 1 - Issue associated with the interaction and interfacing between devices and users in terms of users' abilities, expectations, and limitations with work environments and system design.

 

Instruction for Use Issue C63072; FDA 1318 - Issue associated with the accuracy and appropriateness of any written, printed, graphic or audio/visual matter that is supplied with a medical device or its containers, wrappers; with any matter that accompanies a medical device including instructions related to identification, technical description and use of the medical device provided by the device manufacturer.

·         Inadequate instructions for healthcare professional C63087; FDA 1319 - Issue associated with inaccuracies in any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers; with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device provided by the device manufacturers.

·         Inadequate instructions for non-healthcare professional C63267; FDA 2956 - Issue associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers; with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device provided by the device manufactures that vary from the standard of medical care in a given environment.

Improper or Incorrect Procedure or Method C62862; FDA 2017 - Issue associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers.

Physical Property Issue - LEVEL 1 - Issue associated with any deviations from specifications relating to device physical properties in terms of material integrity, mechanical, manufacturing/shipping, communication/transmission, optical, temperature, chemical, and electronic issues.

Device Ingredient or Reagent Issue C62982; FDA 2910

·         Biocompatibility Issue C63294; FDA 2886

Material Integrity Issue C62968; FDA 2978 - Issue associated with any deviations from device documented performance specifications relating to the limited durability of all material used to construct the device.

 

Degraded C62970; FDA 1153 - Issue associated with a deleterious change in the chemical structure, physical properties, or appearance in the materials that are used in device construction.

Naturally Worn C62906; FDA 2988 - Issue associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

Material Rupture C62965; FDA 1546 - Issue associated with the bursting or tearing apart of a material.

Mechanical Issue C62961; FDA 1384 - Issues associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc.

Dislodged or Dislocated C62950; FDA 2923 - Issue associated with mechanical force that displaces device and/or device components from an intended location.

·         Slippage of Device or Device Component C62840; FDA 1584

Leak C63058; FDA 1354 - Issue associated with the escape of a liquid or gas from the vessel or container in which it is housed.

·         Fluid Leak C63137; FDA 1250

Positioning IssueC63034; FDA 3009 - Issue associated with the forward movement of the device and/or device components to an intended location.

·         Difficult to Position C63230; FDA 1467 - Issue associated with the use of the device in terms of user experiencing difficulty to put device and/or device components in place, even if the operation is being performed according to labeled instructions for use.

·         Difficult to Remove C63228; FDA 1528 - Issue associated with the use of the device in terms of user experiencing difficulty to take out or get rid of a device and/or device components, even if the operation is being performed according to labeled instructions for use.

·         Entrapment of Device or Device Component C63210; FDA 1212 - Issue associated with the device and/or device accessories caught within patient vasculature or tissue.

·         Failure to Advance C63198; FDA 2524 - Issue associated with failure to move the device or its components to an intended location

·         Malposition of Device C63043; FDA 2616 - Issue associated with device being positioned in a location other than intended or specified.

Unintended Movement C62814; FDA 3026 - Issue associated with an undesired movement of device, which may be related to device malfunction, misdiagnosis, or mistreatment.

Migration of Device or Device Component C62917; FDA 1395 - Issue associated with an undesired movement of device and/or device components, related to its movement away from or dislodging from a source.

Maria, I am sure you mean well, but because you keep shoving this down the boars throat, no one cares!!  Overkill just makes people do the opposite!

I know tha band failed youe and others!  Yes Allergan owes us another weight loss surgery.  

Not going to happen as Allergan doesn't give a ****!   But constant mean badgering makes people not give a **** either.

sorry  

This is just reposted b/c the previous post was deleted. Where it not for that I would have had no reason to repost it today. The post was on maybe 12 hrs. so I am assuming that not many got to see it, thus the repost.

As far as  your comment about Allergan not giving a ****So true! When I spoke with one of their reps on Sat. she assured me that someone with Allergan would be getting back in touch with me this wk. Guess what? No phone call! Imagine that?!

This info is public record. It is an excerpt taken directly from DHHS's website:

www.fda.gov/MedicalDevices/Safety/ReportaProblem/EventProble mCodes/ucm134761.htm


REPORT YOUR CRAP, I MEAN LAP-BAND PROBLEMS DIRECTLY TO THE FDA!!!


Post Date: 4/29/11 11:19 pm
I wonder how many surgeons are reporting their band failures to the FDA, which regulates the use of these devices? Let’s see – why would they do that? They’re getting paid by you (and “incentives" by the manufacturers)
* to implant them,
* to fill them,
* to unfill them,
* to resituate them when they slip,
* to reposition the ports when they flip,
* to replace the ports when they fail,
* to explant them when they fail, leak, tear, disintegrate, erode into your stomach, destroy your esophagus, induce scar tissue or adhesions, etc.
* And then to replace them and start all over again!
I'm 100% positive that the above was not taken from the DHHS' website.


Maria, I know that you have had a bad banding experience. That's too band, and I'm sorry for you. I also know that mine could go bad tomorrow.

I also know that you have made it your mission to let the world know that you think the band shouldn't exist, despite the FACT that hundreds of thousands of morbidly obese people have achieved a new life that they never even dreamed possible through the use of the Lap-Band or Realize Band.

I read your spew all the time, and when I first got here I fought you about your hyperbole.
The way you exaggerate things passes emotional passion and drifts into lies.

You know DAMN WELL that many people do well with the band long term.

You know DAMN WELL that the studies that you band haters rely most on depend heavily on old surgical techniques and old understanding of the bands/diet, etc.

Your assertions that every band will fail and that the people that place them are criminal is total BS.
But I have chosen to back off and notr be a fighter here on the forum.

when you say this:

I wonder how many surgeons are reporting their band failures to the FDA, which regulates the use of these devices? Let’s see – why would they do that?


you draw me back out of the shadows.


Physicians are some of the most dedicated professionals in this country. They throw in the decade of their twenties and massive student debt to be allowed the privilege to serve others.

Long days/nights, on call all the time, missing important family functions for serving and/or continued training is just part of it.

There is the untold self-torture when a patient dies or when a frivolous law suit takes one down with lies from a paid ***** of an "expert witness". There are the endless compromises as we try to accommodate everyone's insurance in spite of what would be ideal for the patient.

The constant patient demand that they be treated like royalty for a $10 co-pay or they will make you miserable by reporting you to the state boards...................the list goes on and on.

I don't regret my decision to become a doctor. Most of my physician friends don't either. We work hard and expose our family fortunes to an incredible amount of risk every hour of every day. We do it because it is a calling to serve and to lend whatever we can to those suffering. We love our patients and get a kick out of the occasional triumph.

To throw your ridiculous blanket of hate over the profession, and claim that every action is self serving, is not a reflection of the profession. The doctors that I know follow the rules and strive to serve their patients as hard as they can. Instead it seems to me to be a reflection of how you would act in a similar situation. That you cannot imagine them acting in any different manner is far more a reflection of your life than theirs. You hurt so you attack. Well, get over it. The rest of us aren't like you.


Get more help. Whatever counseling you have been through isn't enough.

There is a great world out there for a you devoid of hate, and bitter resentment.

sincerely,

Docd

its not my place or business, but i am just thining, but if some one is (seemingly so angry) against banding, why waste (their time) being negative and spending time on this forum?? thank goodness for positive people with encouraging thoughtd, advice all with real meaning, good and bad.

Well first of all the lap-band forum is for those of us that have, or have had lap-bands. It's not specifically for bandsters that have lap-bands that work.

Second of all, what you you call "negative" I call realistic. You fill find this out in a few years with YOUR band! ;-)

But to answer your snarky question.............I do it b/c I get thank you's several times a wk. from people that avoided the band because of researching further b/c of what I have said, or from people with failed bands that are greatful to be able to get SUPPORT for their band issues from those that are non-judgemental and don't accuse THEM of causing the band problem.

I don't expect you to understand any of this now. But you will clearly understand it in a few years. :-)

Hell I don't even know where to start with this one. Most of it makes now sense, a lot of it is inaccurate. And to be honest..............I'm really not sure how much of the objection is to what was actually said in the post.............or just your issues with women.

~I'm 100% positive that the above was not taken from the DHHS' website.~

You are correct. I thought I edited out most of what was not on there. I did miss that part.


~the FACT that hundreds of thousands of morbidly obese people have achieved a new life that they never even dreamed possible through the use of the Lap-Band or Realize Band.~

I don't doubt that stat. However that is SHORT TERM! How many bandster do you know that have been successful 5 years? And of those..............how many follow up operations have they had???

~I read your spew all the time, and when I first got here I fought you about your hyperbole.
The way you exaggerate things passes emotional passion and drifts into lies. ~

If you don't like my "spew" you can just stick to the man cave if you prefer. Go tell YOUR lies there!

~You know DAMN WELL that many people do well with the band long term. ~

No. I know DAMN WELL that some people do well with the band SHORT TERM! Get your facts straight!

~You know DAMN WELL that the studies that you band haters rely most on depend heavily on old surgical techniques and old understanding of the bands/diet, etc.~

So? The new band and band techniques don't seem to have any better success, lol.

~Your assertions that every band will fail and that the people that place them are criminal is total BS. ~

It is my belief that the band will fail. It seems like that is the belief of the federal government from the looks of the recent subpoena also, lol. As far as ppl that place them being criminal...............no. I do however feel that it is morally reprehensible!!!

~But I have chosen to back off and notr be a fighter here on the forum.~

Really? You're kidding. Right? Cause it looks like you're trying to start ****

~I wonder how many surgeons are reporting their band failures to the FDA, which regulates the use of these devices? Let’s see – why would they do that? ~

I did not say that. Get your facts straight.


~Physicians are some of the most dedicated professionals in this country.~

I would like to believe that most are.

~They throw in the decade of their twenties and massive student debt to be allowed the privilege to serve others.

Long days/nights, on call all the time, missing important family functions for serving and/or continued training is just part of it.

There is the untold self-torture when a patient dies or when a frivolous law suit takes one down with lies from a paid ***** of an "expert witness". There are the endless compromises as we try to accommodate everyone's insurance in spite of what would be ideal for the patient.

The constant patient demand that they be treated like royalty for a $10 co-pay or they will make you miserable by reporting you to the state boards...................the list goes on and on.~



With all that whining, it sounds like  you don't like being a Dr. Perhaps change occupations? ;-)



~To throw your ridiculous blanket of hate over the profession, and claim that every action is self serving, is not a reflection of the profession.~

Just htf do you get that I hate the profession?

~The doctors that I know follow the rules and strive to serve their patients as hard as they can. Instead it seems to me to be a reflection of how you would act in a similar situation. That you cannot imagine them acting in any different manner is far more a reflection of your life than theirs. You hurt so you attack. Well, get over it. The rest of us aren't like you.~

NONE of that makes any sense at all.

~Get more help. Whatever counseling you have been through isn't enough.~

There you go again.........with that women are crazy **** YOU have issues! Apparently YOU don't like women and YOU especially don't like women that don't agree with you. GET OVER IT! Lol.


~There is a great world out there for a you devoid of hate, and bitter resentment.~

Then stop being so full of hate. That was an extremely hateful post you made to ME! I did NOT attack you in the post. I re-posted some very useful info for bandsters. Now if you choose to believe that nothing ever happens to bandsters that's fine. But some bandsters prefer to be realistic and know how to handle things when the compications start. How dare you try to prevent them from getting that info!