MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-21 for SILASTIC WRIST IMPLANT UNKNOWN manufactured by Unknown.
[14943]
Pt underwent implant placement in left wrist during 1988. She began to complain of pain and swelling approx 2 weeks prior to admission. The pt was taken to surgery where erosion of the implant was found. The implant was removed and the pt underwent ligament reconstruction and tendon interposition, as well as carpometacarpal excisional arthroplasty. Initial surgery was performed at another facility. Implanted 1988. Explanted 4/12/95.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 21917 |
| MDR Report Key | 21917 |
| Date Received | 1995-04-21 |
| Date of Report | 1995-04-20 |
| Date of Event | 1995-04-12 |
| Date Facility Aware | 1995-04-12 |
| Report Date | 1995-04-20 |
| Date Reported to FDA | 1995-04-20 |
| Date Added to Maude | 1995-05-25 |
| 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 |
| 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 WRIST IMPLANT |
| Generic Name | SILASTIC WRIST IMPLANT |
| Product Code | KWM |
| Date Received | 1995-04-21 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Device Availability | N |
| Device Age | 7 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 21982 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-04-21 |