FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 204388
·
Received December 29, 1998
Report
- Report Number
- 2027148-1998-00128
- Event Type
- Injury
- Date Received
- December 29, 1998
- Date of Event
- April 15, 1998
- Report Date
- December 29, 1998
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT IMPLANTED IN RIGHT UPPER VERMILION BORDERS 12/16/1997. ONSET OF INFECTION AND IMPLANT EXTRUSION 02/10/1998 IN PERIORAL AREA. PATIENT TREATED WITH DURICEF 02/10/1998 AND 03/18/1998, AND WITH SEPTRA ON 03/24/1998. THE IMPLANT WAS EXPLANTED 03/30/1998 AND PATIENT TREATED WITH DURICEF. IMPLANT EXPLANTED ON 04/15/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | 4. ANTIBACTERIAL SOAP (12/16/1997 TO 1997),| 2. ZOVIRAX (12/14/1997 TO 12/24/1997),| 3. DURICEF (12/16/1997 TO 12/23/1997),| 12/1997),| 5. SILICON BREAST IMPLANTS (1983 TO 3/31/1998).| 1. BOVINE COLLAGEN IMPLANT TYPE UNKNOWN (FROM |