MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-17 for DOW CORNING * 488-0202 manufactured by Dow Corning Corp..
[18478026]
Explanation of left wrist prosthesis (silastic) due to rupture/fracture of prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 157687 |
| MDR Report Key | 157687 |
| Date Received | 1998-03-17 |
| Date of Report | 1998-02-09 |
| Date of Event | 1998-02-05 |
| Date Facility Aware | 1998-02-05 |
| Report Date | 1998-02-09 |
| Date Added to Maude | 1998-03-20 |
| 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 | DOW CORNING |
| Generic Name | SILASTIC 3RD METATORSAL |
| Product Code | KWM |
| Date Received | 1998-03-17 |
| Returned To Mfg | 1998-02-09 |
| Model Number | * |
| Catalog Number | 488-0202 |
| Lot Number | HH 106280 |
| ID Number | SIZE 2 WS |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 8.5 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 153635 |
| Manufacturer | DOW CORNING CORP. |
| Manufacturer Address | * MIDLAND MI 486860994 US |
| Baseline Brand Name | SILASTIC H.P. 100 SWANSON WRIST JOINT IMPLANT |
| Baseline Generic Name | MAMMARY IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | 4880202 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-03-17 |