MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-28 for JOINT, FINGER SWANSON SIZE 4 (2EA) G4700004 manufactured by Wright Medical Technology, Inc..
[36984567]
Patient Sequence No: 1, Text Type: N, H10
[36984568]
Pre-op diagnosis: rheumatoid arthritis. Procedure(s): hand procedure - right re-do metacarpophalangeal joints (mcpj), silastic metacarpophalangeal joint arthroplasty (smpa) digits 2-5. Post-op diagnosis: same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5396001 |
| MDR Report Key | 5396001 |
| Date Received | 2016-01-28 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-01-19 |
| Report Date | 2015-11-18 |
| Date Reported to FDA | 2015-11-18 |
| Date Reported to Mfgr | 2015-11-18 |
| Date Added to Maude | 2016-01-28 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOINT, FINGER SWANSON |
| Generic Name | PROSTHESIS, FINGER, POLYMER |
| Product Code | MPK |
| Date Received | 2016-01-28 |
| Returned To Mfg | 2015-03-11 |
| Model Number | SIZE 4 (2EA) |
| Catalog Number | G4700004 |
| Lot Number | 047431996 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 1023 CHERRY ROAD MEMPHIS TN 38117 US 38117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-28 |