MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-22 for BIOMET 740041 500410 * manufactured by Biomet Inc..
[182170]
During right knee replacement mallet broke - flat end came off releasing small brown pellets into surgical wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019988 |
| MDR Report Key | 297525 |
| Date Received | 2000-09-22 |
| Date of Report | 2000-09-18 |
| Date of Event | 2000-09-15 |
| Date Added to Maude | 2000-09-27 |
| 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 | 0 |
| 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 | BIOMET |
| Generic Name | MALLET |
| Product Code | HXL |
| Date Received | 2000-09-22 |
| Model Number | 740041 500410 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 287984 |
| Manufacturer | BIOMET INC. |
| Manufacturer Address | 56 BELL DR WARSAW IN 46582 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-09-22 |