MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-31 for ZIMMER OVERHEAD TRAPEZE-HEAVY DUTY 640-003 * manufactured by Zimmer Ortho Surgical Products.
[341067]
Trapeze had a piece that had spread apart. The pt states the trapeze allegedly hit them in the lip. Staff inspected the injured area and pt stated they were ok. Item was removed, repaired and put back in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 499884 |
| MDR Report Key | 499884 |
| Date Received | 2003-07-31 |
| Date of Report | 2003-06-18 |
| Date of Event | 2003-06-04 |
| Date Facility Aware | 2003-06-11 |
| Report Date | 2003-06-18 |
| Date Reported to Mfgr | 2003-07-03 |
| Date Added to Maude | 2003-12-10 |
| 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 | 3 |
| 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 | ZIMMER OVERHEAD TRAPEZE-HEAVY DUTY |
| Generic Name | OVERHEAD TRAPEZE |
| Product Code | ILZ |
| Date Received | 2003-07-31 |
| Model Number | 640-003 |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 488661 |
| Manufacturer | ZIMMER ORTHO SURGICAL PRODUCTS |
| Manufacturer Address | 200 W OHIO AVE DOVER OH 44622 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-31 |