FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 220217
·
Received April 21, 1999
Report
- Report Number
- 2027148-1999-00058
- Event Type
- Injury
- Date Received
- April 21, 1999
- Date of Event
- October 7, 1998
- 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 IN UPPER AND LOWER VERMILION BORDERS 08/01/1998. ONSET OF INFECTION AND IMPLANT EXTRUSION 08/28/1998. PT TREATED WITH CIPRO AND TYLENOL WITH CODEINE NO 3 ON 08/28/1998 WITH BACTROBAN 08/29/1998, WITH AUGMENTIN 500 ON 09/01/1998, WITH CEFTIN AND REVISED 09/02/1998. PT TREATED WITH AUGMENTIN 500 ON 09/16/1998 AND 09/21/1998, REVISED 09/21/1998 AND EXPLANTED AND TREATED WITH CIPRO ON 10/07/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03784/98F281A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention | KEFLEX (1998 TO 08/1998). |