FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 204395
·
Received December 29, 1998
Report
- Report Number
- 2027148-1998-00127
- Event Type
- Injury
- Date Received
- December 29, 1998
- Date of Event
- March 30, 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
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED IN NASOLABIAL FOLDS ON 10/14/1997. ONSET OF INFECTION 01/13/1998 IN NASOLABIAL AREA. PT TREATED 01/13/1998 WITH ERYTHROMCIN, AND ON 01/20/1998 WITH KEFLEX AND CALESTONE. TREATED 02/02/1998 WITH KEFLEX, 02/09/1998 WITH DURICEF AND WESTCORT, 02/12 & 02/23/1998 WITH KENALOG. ON 03/30/1998 IMPLANT EXPLANTED AND PT TREATED WITH WARM COMPRESSES AND KEFLEX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03421/97J191A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | 2. KEFLEX (10/14/1997 TO 10/20/1997),| 5. NEOSPORIN (10/14/1997 TO 1998).| 1. VITAMINS (TO 10/14/1997),| 4. HEAD ELEVATION (10/14/1997 TO 10/17/1997),| 3. COOL COMPRESSES (10/14/1997 TO 10/17/1998), |