MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-15 for UNK UNK. 488-0202 manufactured by Dow Corning Corp..
[64578]
Pt with rheumatoid arthritis s/p with a swanson silastic implant of the left wrist 11 yrs ago. She was found to have a fractured silastic implant in 4/94 and consented to removal of the implant and fusion of the wrist. During surgery, the silicone implant was noted to be in one place but there were fractures noted around the collars of the stem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 97388 |
| MDR Report Key | 97388 |
| Date Received | 1995-02-15 |
| Date of Report | 1994-12-02 |
| Date of Event | 1994-10-31 |
| Date Facility Aware | 1994-11-18 |
| Report Date | 1994-12-02 |
| Date Added to Maude | 1997-06-13 |
| 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 | UNK |
| Generic Name | SILASTIC WRIST IMPLANT |
| Product Code | KWM |
| Date Received | 1995-02-15 |
| Model Number | UNK. |
| Catalog Number | 488-0202 |
| Lot Number | UNK. |
| ID Number | UNK. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 96107 |
| Manufacturer | DOW CORNING CORP. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 380029501 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-02-15 |