FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 191099
·
Received October 9, 1998
Report
- Report Number
- 2027148-1998-00084
- Event Type
- Injury
- Date Received
- October 9, 1998
- Date of Event
- February 2, 1998
- Report Date
- October 9, 1998
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED IN UPPER AND LOWER VERMILION BORDERS ON 12/30/1997. ONSET OF INFECTION, IMPLANT EXTRUSION, AND PALPABLE IMPLANT 02/02/1998. REVISION SURGERY PERFORMED 02/09/1998, EXPLANTATION ON 03/11/1998. REC'D ZYPLAST IMPLANT ON 04/13/1998. IMPLANT EXPLANTED 07/02/1998. IMPLANT TYPE AND SITE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03542/97L161A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | 1. KEFLEX (12/1997 TO 01/1998).| 2. LASER TREATMENT (01/12/1998 TO 01/12/1998). |