MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-04-03 for SWANSON UNK manufactured by Wright Medical Technology, Inc..
[104144992]
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[104144993]
Per voluntary medwatch mw5075136, the patient underwent a surgical procedure to treat the wrist. Allegedly, the patient had a trapezium implanted in the right wrist. The patient was not made aware that the implant was silicon. The patient is complaining of pain in the right wrist and that the implant is eating away the right arm. Patient stated that it is hard to use the right arm which is also the patient dominate hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2018-00016 |
| MDR Report Key | 7391565 |
| Report Source | CONSUMER |
| Date Received | 2018-04-03 |
| Date of Report | 2018-03-05 |
| Date of Event | 2003-01-01 |
| Date Facility Aware | 2018-03-05 |
| Date Mfgr Received | 2018-03-05 |
| Date Added to Maude | 2018-04-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 1023 CHERRY ROAD |
| Manufacturer City | 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer Phone | 901451-631 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWANSON |
| Generic Name | PROSTHESIS, WRIST, CARPAL TRAPEZIUM |
| Product Code | KYI |
| Date Received | 2018-04-03 |
| Model Number | UNK |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-03 |