FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 372931
·
Received January 16, 2002
Report
- Report Number
- 2027148-2001-00019
- Event Type
- Injury
- Date Received
- January 16, 2002
- Date of Event
- October 15, 2001
- Report Date
- January 16, 2002
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED 2001 IN DEEP CHEEK LINES. ONSET OF INFECTION, EXTRUSION, DISPLACEMENT 2001. INCISION SITE ON LEFT SIDE BECAME INFLAMMED, DR PRESCRIBED LEVANQUIN. OVER LAST 5-6 MONTHS, PT HAD PERSISTENT SWELLING WHICH LED TO MIGRATION OF IMPLANTS (DOWN) AND IMPLANT EXTRUSION. THE DEVICE EXPLANTED IN 2001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K05464/01A281A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |