FDA Adverse Event
Injury
Summary report: N
SILASTIC HP100 SWANSON FLEX HINGE TOE SMS
MDR report key: 378233
·
Received February 21, 2002
Report
- Report Number
- 1816403-2002-00002
- Event Type
- Injury
- Date Received
- February 21, 2002
- Report Date
- January 21, 2002
- Manufacturer
- DOW CORNING CORPORATION
- Product Code
- KWH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
REPORTER ALLEGES PT HAD IMPLANT SURGERY ON OR ABOUT 1998 TO RELIEVE ARTHRITIC SYMPTOMS AND PAIN. THE TOE BECAME STIFF AFTER SURGERY AND PT UNDERWENT CONSERVATIVE THERAPY WITHOUT ANY RELIEF. PT UNDERWENT EXPLORATORY SURGERY IN 1999 AND THE IMPLANT WAS FRACTURED AND REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC HP100 SWANSON FLEX HINGE TOE SMS | FLEX HINGE TOE IMP | KWH | DOW CORNING CORPORATION | * | HH073155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |