FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 242739
·
Received October 1, 1999
Report
- Report Number
- 2027148-1999-00164
- Event Type
- Injury
- Date Received
- October 1, 1999
- Date of Event
- April 19, 1999
- Report Date
- September 28, 1999
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED IN UPPER LEFT AND RIGHT AND LOWER VERMILION BORDERS. ONSET OF HERPES SIMPLEX AND INFECTION IN PERIORAL 02/1999. PT TREATED DURING 02/1999 WITH VALTREX, L-LYSINE AND KEFLEX. DURING 04/99 PT TREATED WITH CEFTIN. IN 1999 IMPLANT EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K04116/98K111A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention | 04/13/1999).| BOVINE COLLAGEN IMPLANT TYPE UNKNOWN (TO |