MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-23 for OFFSET DOUBLE CLAMP BAR * 1066-05 manufactured by Zimmer Orthopaedic Surgical Products.
[421418]
Patient's traction collapsed allegedly causing blunt trauma to back of patient head. Patient found moaning and with a large amount of blood. Doctor placed staples in patient's head which resolved bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035617-2005-00005 |
| MDR Report Key | 629254 |
| Report Source | 05 |
| Date Received | 2005-08-23 |
| Date of Report | 2005-07-20 |
| Date of Event | 2005-03-10 |
| Date Facility Aware | 2005-07-20 |
| Report Date | 2005-07-20 |
| Date Reported to Mfgr | 2005-07-20 |
| Date Added to Maude | 2005-08-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOYCE ELKINS |
| 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 | OFFSET DOUBLE CLAMP BAR |
| Generic Name | TRACTION ACCESSORY |
| Product Code | HSQ |
| Date Received | 2005-08-23 |
| Model Number | * |
| Catalog Number | 1066-05 |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 618867 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | 200 WEST OHIO AVE DOVER OH 44622 US |
| Baseline Brand Name | OFFSET DOUBLE CLAMP BAR |
| Baseline Generic Name | TRACTION ACCESSORY |
| Baseline Model No | * |
| Baseline Catalog No | 1066-05 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-23 |