MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-21 for SILASTIC WRIST JOINT IMPLANT HP100 G488-0203 manufactured by Dow Corning Corp..
[12055]
Pt has limited physical activities due to severe rheumatoid arthritis. Fracture occurred during normal daily activity. Surgery replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003461 |
| MDR Report Key | 16295 |
| Date Received | 1994-09-21 |
| Date of Report | 1994-08-06 |
| Date of Event | 1994-03-01 |
| Date Added to Maude | 1994-09-22 |
| 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 | SILASTIC WRIST JOINT IMPLANT |
| Generic Name | SILASTIC WRIST JOINT IMPLANT |
| Product Code | KWM |
| Date Received | 1994-09-21 |
| Model Number | HP100 |
| Catalog Number | G488-0203 |
| Lot Number | H.H. |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16228 |
| Manufacturer | DOW CORNING CORP. |
| Manufacturer Address | MIDLAND MI 48686 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-21 |