FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 188989
·
Received September 22, 1998
Report
- Report Number
- 2027148-1998-00061
- Event Type
- Injury
- Date Received
- September 22, 1998
- Date of Event
- July 15, 1998
- Report Date
- September 22, 1998
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED 06/01/1998 IN THE LOWER LIP. ONSET OF INFECTION AT LIPS ON 07/06/1998. PT TREATED WITH ANTIBIOTIC 07/13/1998. THE IMPLANT WAS EXPLANTED 07/15/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03619/98C041A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |