MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-30 for MEDPOR IMPLANT 9859 manufactured by Porex Surgical.
[1304526]
The doctor reported that the patient required removal of a medpor temporal implant after developing an infection. The doctor stated that the surrounding thin radiated tissue did not support the implant. The doctor stated that the patient is healing well, and is "stable with defect".
Patient Sequence No: 1, Text Type: D, B5
[8365064]
A copy of the current medpor surgical implant instructions for use is enclosed with contraindication highlighted. This document accompanies each medpor implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2009-00012 |
| MDR Report Key | 1520585 |
| Report Source | 05 |
| Date Received | 2009-10-30 |
| Date of Report | 2009-10-29 |
| Date of Event | 2009-09-25 |
| Date Mfgr Received | 2009-10-05 |
| Device Manufacturer Date | 2008-06-18 |
| Date Added to Maude | 2009-11-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART RD. |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JOF |
| Date Received | 2009-10-30 |
| Model Number | NA |
| Catalog Number | 9859 |
| Lot Number | D288F05 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-10-30 |