MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-27 for MORELAND CEMENT REMOVAL INSTRUMENT * manufactured by Depuy Orthopaedics, Inc..
[392303]
Manufacturer of insrument trays are providing unacceptable sterilization instructions for standard hosp sterilization cycles. Some companies are not able to provide sterilization instructions in writing when requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034339 |
| MDR Report Key | 566627 |
| Date Received | 2004-12-27 |
| Date of Report | 2004-12-22 |
| Date Added to Maude | 2005-01-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORELAND CEMENT REMOVAL INSTRUMENT |
| Generic Name | STERILIZATION INSTRUCTIONS |
| Product Code | LZV |
| Date Received | 2004-12-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 556420 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDICS DRIVE WARSAW IN 46581 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-27 |