FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 227892
·
Received June 18, 1999
Report
- Report Number
- 2027148-1999-00071
- Event Type
- Injury
- Date Received
- June 18, 1999
- Date of Event
- November 3, 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
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT IMPLANTED IN 1998 IN BOTH UPPER VERMILION BORDERS. ONSET OF IMPLANT EXTRUSION AND INFECTION 09/08/1998 IN PERIORAL. PATIENT TREATED WITH TROVAN 09/08/1998 AND REVISED 09/22/1998 AND 09/24/1998. PATIENT TREATED WITH TROVAN AND DARVOCET 10/17/1998. IN 1998 IMPLANT EXPLANTED AND PATIENT TREATED WITH ZITHROMAX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC | NA | K03422/97J201A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |