FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 196789
·
Received November 12, 1998
Report
- Report Number
- 2027148-1998-00109
- Event Type
- Injury
- Date Received
- November 12, 1998
- Date of Event
- April 3, 1998
- Report Date
- November 12, 1998
- Manufacturer
- TISSUE TECHNOLOGIES, INC
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED 03/20/1998 IN THE UPPER AND LOWER VERMILION BORDERS. ONSET OF INFECTION 04/02/1998. PT TREATED WITH CIPRO 04/02/1998. ON 04/03/1998 THE IMPLANT WAS EXPLANTED AND ICE APPLIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC | NA | K03500/97K231A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention | MOTRIN (TO 03/20/1998)| KEFLEX (03/19/1998 TO 03/21/1998) |