MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-10-16 for CROSS CLAMP * 1042-04 manufactured by Zimmer Orthop Surgical Products.
[303513]
Post-op patient in new hillrom total care bed with new 4 poster overhead frame (zimmer) - used the overhead trapeze to pull themselves up in bed and the cross clamp allegedly broke in half, causing the trapeze to fall onto patient resulting in a laceration on apparatus hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035617-2003-00004 |
| MDR Report Key | 490818 |
| Report Source | 05,06 |
| Date Received | 2003-10-16 |
| Date of Report | 2003-09-19 |
| Date of Event | 2003-09-02 |
| Date Facility Aware | 2003-09-16 |
| Report Date | 2003-09-19 |
| Date Reported to Mfgr | 2003-09-16 |
| Date Mfgr Received | 2003-09-16 |
| Date Added to Maude | 2003-10-24 |
| 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 | 3303649483 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROSS CLAMP |
| Generic Name | TRACTION ACCESSORIES |
| Product Code | ILZ |
| Date Received | 2003-10-16 |
| Model Number | * |
| Catalog Number | 1042-04 |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 479545 |
| Manufacturer | ZIMMER ORTHOP SURGICAL PRODUCTS |
| Manufacturer Address | 200 W. OHIO AVENUE DOVER OH 44622 US |
| Baseline Brand Name | CROSS BAR |
| Baseline Catalog No | 1042-04 |
| Baseline Device Family | TRACTION ACCESSORIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| 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 | 2003-10-16 |