FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 196962
·
Received November 12, 1998
Report
- Report Number
- 2027148-1998-00107
- Event Type
- Injury
- Date Received
- November 12, 1998
- Date of Event
- January 19, 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
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED IN NASOLABIAL FOLDS 01/06/1998. ONSET OF SYMPTOMS 01/06/1998. SYMPTOMS INCLUDE SWELLING, BRUISE, IMPLANT EXTRUSION AND INFECTION. ON 01/15/1998 PT TREATED WITH KEFLEX. THE IMPLANT WAS EXPLANTED 01/19/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03541/97L101A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | 2. ZYPLAST IMPLANT (TO 10/03/1997)| HEAD ELEVATION (01/06/1998 TO 01/1998)| 3. KEFLEX (01/06/1998 TO 01/13/1998)| 1. ZYDERM IMPLANT (TO 10/03/1997)| 4. COOL COMPRESSES (01/06/1998 TO 01/08/1998) |