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 RS1805 2006-2007 manufactured by Alimed.
[20884759]
Resident was using a drop seat in her wheelchair which broke unexpectedly, while she was sitting in the chair, resulting in a fall to the floor. Product is manufactured by qualcare product number. The co was notified on 11/2/06 of the product failure, the item was returned to them, and they subsequently provided an identical replacement product. The new product was installed on/about 11/9/06. There has now been a failure in the replacement product. In 2004, a breakage in a different section of the device occurred, which again resulted in a fall to the floor. A separate product problem report to be filed after this one to reflect this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002624 |
| MDR Report Key | 865485 |
| Date Received | 2007-06-11 |
| Date of Report | 2007-06-11 |
| Date of Event | 2006-11-01 |
| 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 |
| Returned To Mfg | 2006-11-06 |
| Model Number | RS1805 |
| Catalog Number | 2006-2007 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 851448 |
| Manufacturer | ALIMED |
| Manufacturer Address | 297 HIGH ST DEDHAM MA 02026 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-11 |