MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-11 for QUALCARE BY ALIMED RS 1805 2006-2007 manufactured by Alimed.
[652155]
Resident was sitting in her wheelchair, which had the qualcare by alimed drop seat installed, when the device suddenly and unexpectedly broke causing the resident to fall to the floor. The device had only been in use approx. 6 mos. And verification was made that it was installed properly at the time of failure. A previous device failure had been reported to the co in 11/06, and the product in use was a replacement product provided by the vendor. At the request of our state survey team, efforts were made to determine if the co had experienced similar complaints of product failure for this particular item, with their response being "there has never been a report of a breakage". We had reported a prior breakage in 11/06 as noted above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002625 |
| MDR Report Key | 865486 |
| Date Received | 2007-06-11 |
| Date of Report | 2007-06-11 |
| Date of Event | 2007-05-24 |
| Date Added to Maude | 2007-06-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUALCARE BY ALIMED |
| Generic Name | DROP SEAT |
| Product Code | KNO |
| Date Received | 2007-06-11 |
| Model Number | RS 1805 |
| Catalog Number | 2006-2007 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 851454 |
| Manufacturer | ALIMED |
| Manufacturer Address | 297 HIGH ST DEDHAM MA 02026 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-11 |