FDA Adverse Event
Injury
Summary report: N
SILASTIC GREAT TOE IMPLANT
MDR report key: 382240
·
Received March 14, 2002
Report
- Report Number
- 1816403-2002-00003
- Event Type
- Injury
- Date Received
- March 14, 2002
- Report Date
- February 14, 2002
- Manufacturer
- DOW CORNING CORPORATION
- Product Code
- KWD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER ALLEGES PATIENT COMPLAINED OF PAIN IN LEFT FOOT WITH MASS GANGLION CYST AND NEEDED IMPLANT REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC GREAT TOE IMPLANT | GREAT TOE IMPLANT | KWD | DOW CORNING CORPORATION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |