MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-05-23 for ZIMMER TRAPEZE * 265-11 manufactured by Zimmer Patient Care.
[222185]
The trapeze allegedly broke at the base of the offset bar at the headboard. Patient fell onto back with injury report being noted as "no injury or disability. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035617-2001-00010 |
| MDR Report Key | 335253 |
| Report Source | 06 |
| Date Received | 2001-05-23 |
| Date of Report | 2001-05-02 |
| Date of Event | 2001-02-06 |
| Date Facility Aware | 2001-05-02 |
| Date Mfgr Received | 2001-05-02 |
| Date Added to Maude | 2001-06-01 |
| 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 TRAPEZE |
| Generic Name | TRAPEZE |
| Product Code | HSQ |
| Date Received | 2001-05-23 |
| Model Number | * |
| Catalog Number | 265-11 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 324599 |
| Manufacturer | ZIMMER PATIENT CARE |
| Manufacturer Address | 2021 OLD MOUNTAIN RD. STATESVILLE NC 28677 US |
| Baseline Brand Name | BED FRAME |
| Baseline Generic Name | BED FRAME |
| Baseline Model No | NA |
| Baseline Catalog No | 265-11 |
| Baseline ID | TRAPEZE |
| Baseline Device Family | TRACTION ACCESSORIES |
| 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 | 2001-05-23 |