FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 254940
·
Received December 15, 1999
Report
- Report Number
- 2027148-1999-00220
- Event Type
- Injury
- Date Received
- December 15, 1999
- Date of Event
- July 21, 1999
- Report Date
- December 15, 1999
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED IN 1999 IN THE LOWER AND UPPER LEFT VERMILION BORDERS. ONSET OF INFECTION AND IMPLANT EXTRUSION 06/25/1999. IMPLANT REVISED 06/25/1999 AND 06/30/1999. IMPLANT EXPLANTED 1999 AND PT TREATED WITH KEFLEX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03981/98M171A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |