FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 242477
·
Received September 27, 1999
Report
- Report Number
- 2027148-1999-00176
- Event Type
- Injury
- Date Received
- September 27, 1999
- Date of Event
- April 27, 1999
- 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 THE RIGHT AND LEFT UPPER VERMILION BORDERS. ONSET OF INFECTION 4/1/1999. PT TREATED WITH CEPHALEXIN 4/25/1999. THE IMPLANT WAS EXPLANTED AND THE PT TREATED WITH LEVAQUIN IN 1999.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K04116/98K111A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |