FDA Adverse Event
Injury
Summary report: N
MEDPOR FACIAL IMPLANT
MDR report key: 571242
·
Received February 4, 2005
Report
- Report Number
- 1057129-2005-00003
- Event Type
- Injury
- Date Received
- February 4, 2005
- Manufacturer
- POREX SURGICAL, INC.
- Product Code
- FWP
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT RECEIVED A MALAR IMPLANT AND A PARANASAL IMPLANT AND DEVELOPED A FISTULA WITH EXTRUDATE. THE IMPLANT WAS PLACED IN 2003. AND THE PT PRESENTED A FISTULA THE FOLLOWING MONTH. FISTULA WAS DRAINED THROUGH EXCISION, TREATED A SUTURED. FISTULA REAPPEARED IN 2004. IMPLANT WAS REMOVED 7 MONTH LATER. THE INCIDENT WAS REPORTED TO POREX SURGICAL BY THE DISTRIBUTOR 2 MONTHS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR FACIAL IMPLANT | FACIAL AUGMENTATION AND RECONSTRUCTION IMPLANT | FWP | POREX SURGICAL, INC. | 9525 | 088080602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |