MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-04-24 for ZIMMER CLAMP ASSEMBLY * 00-0640-042-00 manufactured by Zimmer Patient Care.
[224785]
Pt was pulling self up with trapeze bar when the trapeze frame bracket allegedly broke and struck pt in the head, causing a raised area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035617-2001-00007 |
| MDR Report Key | 329081 |
| Report Source | 05,06 |
| Date Received | 2001-04-24 |
| Date of Report | 2001-03-05 |
| Date of Event | 2001-02-28 |
| Date Facility Aware | 2001-03-12 |
| Report Date | 2001-03-05 |
| Date Reported to Mfgr | 2001-03-12 |
| Date Mfgr Received | 2001-03-12 |
| Date Added to Maude | 2001-04-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA OSORIO |
| Manufacturer Street | 200 W. OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER CLAMP ASSEMBLY |
| Generic Name | TRAPEZE CLAMP ASSEMBLY |
| Product Code | HSQ |
| Date Received | 2001-04-24 |
| Model Number | * |
| Catalog Number | 00-0640-042-00 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 311124 |
| Manufacturer | ZIMMER PATIENT CARE |
| Manufacturer Address | 2021 OLD MOUNTAIN ROAD STATESVILLE NC 28677 US |
| Baseline Brand Name | ZIMMER CLAMP ASSEMBLY |
| Baseline Generic Name | TRAPEZE CLAMP |
| Baseline Catalog No | 00-0640-042-00 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-04-24 |