MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-21 for MEDPOR IMPLANT 82020 manufactured by Porex Surgical.
[18211071]
Dates of implantation: (b)(6) 2008. (b)(6) 2008. (b)(6) 2008. Lot number info was not provided by the doctor for further eval, therefore, no conclusion can be drawn. No info regarding the condition of the pt after removal of the implants could be obtained from the surgeon.
Patient Sequence No: 1, Text Type: N, H10
[18372630]
The doctor stated that he had three pts that received a medpor titan cranial curve implant in (b)(6) 2008. The doctor stated that each pt developed an infection approx five to six weeks after surgery. The doctor reported that the medpor implants were removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2009-00002 |
| MDR Report Key | 1392904 |
| Report Source | 05 |
| Date Received | 2009-05-21 |
| Date of Report | 2009-05-20 |
| Date Mfgr Received | 2009-04-24 |
| Date Added to Maude | 2011-03-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HPZ |
| Date Received | 2009-05-21 |
| Model Number | NA |
| Catalog Number | 82020 |
| Lot Number | UNK |
| 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 | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-21 |