MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-10 for DOW CORNING UNK manufactured by *.
[498204]
Having been seen by a dr who x-rayed my left wrist because of various complications, i. E. , wrist spasms, prosthesis and bone cysts. Dr later determined this was a condition called "silicon synovitis. " implant was removed and a "foll" biopsy was done. Awaiting results that are in and will send them upon request.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036298 |
| MDR Report Key | 751709 |
| Date Received | 2005-08-10 |
| Date of Report | 2005-08-03 |
| Date of Event | 2005-05-21 |
| Date Added to Maude | 2006-08-21 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | DOW CORNING |
| Generic Name | WRIST IMPLANT (SILICONE) |
| Product Code | KIG |
| Date Received | 2005-08-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 739515 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Hospitalization; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit | 2005-08-10 |