FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 173926
·
Received June 22, 1998
Report
- Report Number
- 2027148-1998-00039
- Event Type
- Injury
- Date Received
- June 22, 1998
- Date of Event
- February 10, 1998
- Report Date
- June 22, 1998
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED INTO THE NASOLABIAL FOLDS. VASOTEC, PREMARIA, PROVERA, VITAMEN E, CALCIUM, MINOCYCLINE, HEAD ELEVATION, COOL COMPRESSES AND BACITRACIN PRESCRIBED TO 12/08/1997. ONSET OF INFECTION AND IMPLANT DISPLACEMENT IN NASOLABIAL FOLD AREA 12/15/1997. 12/17/1997 SEPTRA PRESCRIBED. 2/10/1998 REMOVAL DIFFICULTIES IN EXPLANTING DEVICE. SEPTRA AND BACETRACIN PRESCRIBED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03449/97K101A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | 9. BACITRACIN (12/08/1997 TO 12/12/1997).| 5. CALCIUM (FROM 12/08/1997),| 4. VITAMIN E (FROM 12/08/1997),| 3. PROVERA (FROM 12/08/1997),| 6. MINOCYCLINE (12/08/1997 TO 12/15/1997),| 8. COOL COMPRESSES (12/08/1997 TO 12/10/1997),| 1. VASOTEC (FROM 12/08/1997),| 7. HEAD ELECATION (12/08/1997 TO 12/11/1997),| 2. PREMARIN (FROM 12/08/1997), |