FDA Adverse Event
Other
Summary report: N
MEDPOR IMPLANT
MDR report key: 715037
·
Received May 15, 2006
Report
- Report Number
- 1057129-2006-00007
- Event Type
- Other
- Date Received
- May 15, 2006
- Report Date
- April 11, 2006
- Manufacturer
- POREX SURGICAL, INC.
- Product Code
- FWP
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE DOCTOR REPORTED THAT A PT RECEIVED AN IMPLANT SEVERAL MONTHS AGO. THE DOCTOR STATED THAT THE PT DEVELOPED AN INFECTION. THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED FOLLOWING POSSIBLE CELLULITIS. THE DOCTOR EXPLAINED THAT THE PROBLEM WAS LIKELY ASSOCIATED WITH COMMUNICATION WITH THE FRONTAL SINUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR IMPLANT | FACIAL RECONSTRUCTION | FWP | POREX SURGICAL, INC. | NA | 0071210804H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |