FDA Adverse Event
Injury
Summary report: N
MEDPOR IMPLANT
MDR report key: 611430
·
Received June 6, 2005
Report
- Report Number
- 1057129-2005-00020
- Event Type
- Injury
- Date Received
- June 6, 2005
- Report Date
- June 3, 2005
- Manufacturer
- POREX SURGICAL, INC.
- Product Code
- FWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE DOCTOR STATED THAT THE PT WAS A NASAL RECONSTRUCTIVE PT. HE PLACED A CANTILEVERED DORSAL STRUT MADE FROM THE MEDPOR NASAL ARCH IMPLANT AND A COLUMELLAR STRUT. THE PT DEVELOPED AN INFECTION AND THE MEDPOR NASAL ARCH IMPLANT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR IMPLANT | FACIAL RECONSTRUCTION | FWP | POREX SURGICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |