FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 248649
·
Received November 2, 1999
Report
- Report Number
- 2027148-1999-00186
- Event Type
- Injury
- Date Received
- November 2, 1999
- Date of Event
- June 13, 1999
- Report Date
- November 2, 1999
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED IN 1999 IN NASOLABIAL FOLDS. ONSET OF INFECTION AND IMPLANT DISPLACEMENT 04/06/1999. PT TREATED CIPRO 05/13/1999. IMPLANT WAS EXPLANTED IN 1999.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | 2. MAXZIDE (TO 03/12/1999)| 3. ZITHROMAX (02/12/1999 TO 03/12/1999)| 1. SULAR (TO 03/12/1999)| 4. LIDOCAINE WITH EPINEPHRINE (2/12/99 TO 3/12/99) |