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 |