MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-23 for SWANSON G4260010 manufactured by Wright Medical Technology, Inc..
[106184757]
The product was not returned; however, a radiographic image was provided. Review of the provided image shows two implanted swanson devices with grommets.
Patient Sequence No: 1, Text Type: N, H10
[106184758]
It was reported that the patient underwent a surgical procedure with grommets implanted in the right thumb and index finger mp joint. Allegedly, the patient has complained of pain and swelling in the insertion site as well as being feverish since the surgery. X-rays did not indicate any problems. Crp was (b)(6). The patient took antibiotics (b)(6) but it was not responding. The patient is undergoing testing to see if there is an allergic reaction to silicon or titanium.
Patient Sequence No: 1, Text Type: D, B5
[111227911]
Patient Sequence No: 1, Text Type: N, H10
[111227912]
The patient underwent allergy testing with a skin patch. The test result is negative. The pain at the thumb is improving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2018-00025 |
| MDR Report Key | 7450886 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-23 |
| Date of Report | 2018-03-26 |
| Date Facility Aware | 2018-03-26 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2018-04-23 |
| 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, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2018-04-23 |
| Model Number | G4260010 |
| Lot Number | 1573904 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-04-23 |