MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-31 for WRIST IMPLANT * 48809293 4880 503W manufactured by Dow Corning Corp..
[36087]
Failed right wrist implant with fracture of silastic implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 53118 |
| MDR Report Key | 53118 |
| Date Received | 1996-07-31 |
| Date of Report | 1996-01-25 |
| Date Facility Aware | 1996-01-12 |
| Report Date | 1996-01-25 |
| Date Reported to Mfgr | 1996-01-25 |
| Date Added to Maude | 1996-12-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WRIST IMPLANT |
| Generic Name | SWANSON WRIST JOINT IMPLANT GROMMET 3 WP, 3WD |
| Product Code | KWM |
| Date Received | 1996-07-31 |
| Model Number | * |
| Catalog Number | 48809293 4880 503W |
| Lot Number | HH096295 04821686 |
| ID Number | * |
| Operator | NOT APPLICABLE |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 53740 |
| Manufacturer | DOW CORNING CORP. |
| Manufacturer Address | * MIDLAND MI 48686 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-07-31 |