FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 204399
·
Received December 29, 1998
Report
- Report Number
- 2027148-1998-00130
- Event Type
- Injury
- Date Received
- December 29, 1998
- Date of Event
- June 12, 1998
- Report Date
- December 29, 1998
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT IMPLANTED IN NASOLABIAL FOLDS, UPPER/LOWER VERMILION BORDERS 11/26/1997. ONSET OF BRUISE, INFECTION, IMPLANT EXTRUSION AND EDEMA 11/26/1997 IN PERIORAL. ON 12/22/1997 PATIENT REVISED AND TREATED WITH KEFLEX. ON 01/13/1998 PATIENT REVISED AND TREATED WITH KENALOG. PATIENT TREATED WITH KENALOG 02/12/1998. ON 02/23/1998 PATIENT REVISED AND TREATED WITH AUGMENTIN. PATIENT TREATED WITH AUGMENTIN ON 03/02/1998. ON 03/27/1998 IMPLANT EXPLANTED. PATIENT TREATED WITH CIPRO ON 04/20/1998 AND 05/12/1998, EXPLANTATION ON 06/12/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03047/K03410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | 2. KEFLEX (11/26/1997 TO 12/01/1997),| 3. ANTIBIOTIC (11/26/1997 TO 12/01/1997),| TO 09/1997),| 4. COOL COMPRESSES (11/26/1997 TO 12/01/1997).| 1. BOVINE COLLAGEN IMPLANT TYPE UNKNOWN (05/1996 |