FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 207223
·
Received January 20, 1999
Report
- Report Number
- 2027148-1999-00036
- Event Type
- Injury
- Date Received
- January 20, 1999
- Manufacturer
- TISSUE TECHNOLGIES, 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
PT IMPLANTED 12/26/1997 NASOLABIAL FOLDS AND UPPER VERMILION BORDERS. ONSET OF INFECTION AND IMPLANT EXTRUSION 02/1998. PT TREATED WITH THE FOLLOWING: 02/17/1998 CIPRO, 02/24/1998 ROCEPHIN. PT REVISED 02/24/1998 AND 03/20/1998 AND TREATED WITH ROCEPHIN AND CIPRO. IMPLANT EXPLANTED 06/26/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLGIES, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention | ROCEPHIN (12/26/1998 TO 12/26/1998)| ICE (12/26/1998 TO 12/27/1998)| KEFLEX (12/26/1997 TO 01/01/1998) |