URGENT! Contact info to report FAILED BANDS!!!
If you have a Lap-Band I will have the contact info for their failed bands added to this in the next few days.
Also Diana from the DS forum has gotten us the contact info for reporting the failed bands to the RDA. Please report the Realize Band failure to them as well!!!
Both posts are listed below:
For any of you out there that have the Realize Band that doesn't work here is the contact info to try to get this resolved:
Janice Hinsey, RN MBA | Sr Regulatory Reporting Specialist EES
800-873-3636
Do I actually expect them to help? NO! However they do need to start logging all the complaints about the Realize Band. Also please post on this thread the response you get from EES with this matter.
Here is the info to report your failed band to the FDA:
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!
Why would they want to tell the FDA about the earning power of their cash cows?
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.
