FDA Adverse Event
Other
Summary report: N
MEDPOR IMPLANT
MDR report key: 861724
·
Received June 4, 2007
Report
- Report Number
- 1057129-2007-00010
- Event Type
- Other
- Date Received
- June 4, 2007
- Date of Event
- July 25, 2006
- Report Date
- May 30, 2007
- Manufacturer
- POREX SURGICAL
- Product Code
- FTM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS FOR BOTH LOTS WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA HAVE BEEN VERIFIED AS COMPLYING WITH THE MEDPOR IMPLANT SPEC. A COPY OF THE CURRENT INSTRUCTIONS FOR USE AND LABELING ARE ENCLOSED. ADDITIONAL CATALOG#: 9520, ADDITIONAL LOT#: A082G15, ADDITIONAL EXPIRATION DATE: 08/2015, ADDITIONAL DEVICE MANUFACTURE DATE: 08/2005.
Description of Event or Problem · 1
DURING A REVISION RHINOPLASTY SURGERY, THE DOCTOR PLACED A LEFT MEDPOR PARANASAL IMPLANT AND A RIGHT MEDPOR PARANASAL IMPLANT. THE IMPLANTS WERE PLACED INTRA ORALLY AND WERE SECURED WITH BIOGLUE. APPROX SIX WEEKS AFTER THE SURGERY, THE PT DEVELOPED AN INFECTION AND THE DOCTOR REMOVED THE NASAL IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR IMPLANT | FACIAL RECONSTRUCTION | FTM | POREX SURGICAL | NA | B252B04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Other |