MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-03-05 for OFF SET DOUBLE CLAMP BAR * 265-11 manufactured by Zimmer Ortho Surgical Products.
[253235]
Pt was in bed, 2 staff members present. Pt was receiving assistance to get out of bed the pt had bilateral knee replacements. The overbed trapeze bar allegedly broke at the connection site at the steel connector. 2 staff members caught the bar and the pt was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035617-2002-00001 |
| MDR Report Key | 380736 |
| Report Source | 05,06 |
| Date Received | 2002-03-05 |
| Date of Report | 2002-02-04 |
| Date of Event | 2001-12-19 |
| Date Facility Aware | 2002-02-04 |
| Report Date | 2001-12-19 |
| Date Reported to Mfgr | 2002-02-04 |
| Date Mfgr Received | 2002-02-04 |
| Date Added to Maude | 2002-03-12 |
| 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 WEST OHIO AVE |
| 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 | OFF SET DOUBLE CLAMP BAR |
| Generic Name | TRACTION ACCESSORY |
| Product Code | HSQ |
| Date Received | 2002-03-05 |
| Returned To Mfg | 2002-02-04 |
| Model Number | * |
| Catalog Number | 265-11 |
| 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 | A |
| Device Sequence No | 1 |
| Device Event Key | 369787 |
| Manufacturer | ZIMMER ORTHO SURGICAL PRODUCTS |
| Manufacturer Address | 200 W. OHIO AVE. DOVER OH 44622 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. Required No Informationntervention | 2002-03-05 |