MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-16 for * manufactured by Metro Medical Equipment, Inc..
[450464]
The patient was found on floor on his side. He stated that he was trying to transfer from bed to chair and fell. No injuries noted. Assisted back to bed. Staff further describes the patient leaning forward while sitting in his wheelchair that has the amputee board attached. The weight of the patient leaning forward evidently caused the wheel chair to tip forward, breaking the amputee board from device that attaches it to the chair. This device was not made available to the reporter and the manufacturer's catalog is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 687617 |
| MDR Report Key | 687617 |
| Date Received | 2006-02-16 |
| Date of Report | 2006-01-25 |
| Date of Event | 2005-07-22 |
| Report Date | 2006-01-25 |
| Date Reported to FDA | 2006-02-16 |
| Date Added to Maude | 2006-03-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | AMPUTEE LEG BOARD |
| Product Code | KNO |
| Date Received | 2006-02-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 676824 |
| Manufacturer | METRO MEDICAL EQUIPMENT, INC. |
| Manufacturer Address | 12985 WAYNE RD. LIVONIA MI 48150 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-16 |