MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-01 for UNK manufactured by *.
[356048]
Pt admitted to hosp for arthrodesis of left wrist with bone graft and removal of silastic wrist implant. Original implant was placed 1987. Indications for pt's surgery were chronic severe pain, limited motion, extensive erosions of the carpus and distal radius and ulna. This was secondary to silicone erosion and severe functional limitations secondary to pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 541589 |
| MDR Report Key | 541589 |
| Date Received | 2004-09-01 |
| Date of Report | 2004-08-20 |
| Date of Event | 2004-03-01 |
| Date Facility Aware | 2004-08-12 |
| Report Date | 2004-08-20 |
| Date Reported to FDA | 2004-08-20 |
| Date Added to Maude | 2004-09-02 |
| 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 | 3 |
| 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 | UNK |
| Generic Name | SILASTIC WRIST PROSTHESIS |
| Product Code | KWM |
| Date Received | 2004-09-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 17 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 530915 |
| Manufacturer | * |
| Manufacturer Address | * UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-01 |