FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 192737
·
Received October 19, 1998
Report
- Report Number
- 2027148-1998-00090
- Event Type
- Injury
- Date Received
- October 19, 1998
- Date of Event
- June 1, 1998
- Report Date
- October 19, 1998
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED IN NASOLABIALS AND UPPER AND LOWER VERMILION BORDERS 06/19/1998. ONSET ON INFECTION AND OVERCORRECTION 06/1998 IN NASOLABIAL AND PERIORAL. LEVAQUIN PRESCRIBED 07/08/1998. IMPLANT(S) EXPLANTED 07/20/1998 AND 08/11/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03601/K03638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention | CEFTIN (06/18/1998 TO 06/29/1998)| SALINE BREAST IMPLANT(S) (FROM 06/29/1998), |