FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 227878
·
Received June 18, 1999
Report
- Report Number
- 2027148-1999-00072
- Event Type
- Injury
- Date Received
- June 18, 1999
- Date of Event
- November 2, 1998
- Report Date
- June 18, 1999
- Manufacturer
- TISSUE TECHNOLOGIES, INC
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT IMPLANTED IN 1998 IN THE UPPER AND LOWER VERMILION BORDERS. ONSET OF INFECTION AND WOUND DRAINAGE 10/07/1998 IN PERIORAL. PATIENT TREATED WITH KEFLEX 10/07/1998, REVISED AND DEBRIDED 10/21/1998. IMPLANT EXPLANTED IN 1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC | NA | K03874/98H081A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | 2. ZYDERM IMPLANT (TO 07/17/1998),| 3. KEFLEX (10/1998 TO 1998).| 1. ZYPLAST IMPLANT (TO 09/23/1998), |