MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-03 for SWANSON G4260105 manufactured by Wright Medical Technology, Inc..
[156728951]
The lot of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device. However, the suspect devices in use are lot # 1620977 and # 1643492. Manufacture date for lot 1620977 is 02/08/2018; manufacture date for lot 1643492 is 12/12/2018. 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
[156728952]
Allegedly the patient underwent a surgical procedure. It was reported that the patient had an infection 6 weeks post op which was treated with iv antibiotics. The symptoms continue to worsen. The surgeon thinks the patient may have an allergic reaction to the implants based on inflammatory markers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2019-00120 |
| MDR Report Key | 8957265 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-03 |
| Date of Report | 2019-08-05 |
| Date of Event | 2019-07-31 |
| Date Mfgr Received | 2019-08-05 |
| Date Added to Maude | 2019-09-03 |
| 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 Contact | MR MATTHEW PARRISH |
| Manufacturer Street | 1023 CHERRY RD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 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, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2019-09-03 |
| Model Number | G4260105 |
| Lot Number | SEE H10 |
| 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 ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-03 |