MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-22 for UNK manufactured by Unk.
[20244140]
Pt had surgery to remove a fractured trapezial implant of the left thumb. Prosthesis had broken at the base of it's stem and was removed in 2 pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 424013 |
| MDR Report Key | 424013 |
| Date Received | 2002-10-22 |
| Date of Report | 2002-10-22 |
| Date of Event | 2002-10-18 |
| Date Facility Aware | 2002-10-18 |
| Report Date | 2002-10-22 |
| Date Reported to FDA | 2002-10-22 |
| Date Added to Maude | 2002-10-28 |
| 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 | UNK |
| Generic Name | TRAPEZIAL SILICONE IMPLANT |
| Product Code | MIB |
| Date Received | 2002-10-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 413065 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK UNK * UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-10-22 |