MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-03 for SILASTIC IMPLANT 4880205 manufactured by Wright Dow Corning.
[14204]
Wrist implant removed due to breakage of device. Implanted 6 yrs ago. Pt denies history of trauma/incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26610 |
| MDR Report Key | 26610 |
| Date Received | 1995-08-03 |
| Date of Report | 1995-05-11 |
| Date of Event | 1995-05-10 |
| Date Added to Maude | 1995-10-06 |
| 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 | SILASTIC IMPLANT |
| Generic Name | WRIST IMPLANT |
| Product Code | KWM |
| Date Received | 1995-08-03 |
| Catalog Number | 4880205 |
| Lot Number | HH126320 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27359 |
| Manufacturer | WRIGHT DOW CORNING |
| Manufacturer Address | 5677 AIRLINE RD ARLINGTON TN 38002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 1995-08-03 |