MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-04 for MEDPOR IMPLANT 6326 manufactured by Porex Surgical.
[1195763]
The surgical coordinator stated that the pt received a medpor sphere implant in (b)(6) 2005. The coordinator stated that a sclera graft was performed in (b)(6) 2009, due to implant erosion. The coordinator reported that in (b)(6) 2009 the area once again showed erosion and an infection. The coordinator reported that in (b)(6) 2009, the implant was removed and an acrylic implant was placed. The coordinator reported that the pt is in good condition.
Patient Sequence No: 1, Text Type: D, B5
[8463842]
The surgery coordinator stated that the implant was in good condition after removal. Following a review of the device history record for lot number 6327-193160904, it was determined that all processes and test criteria are within the medpor implant finished product specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2009-00003 |
| MDR Report Key | 1400096 |
| Report Source | 05 |
| Date Received | 2009-06-04 |
| Date of Report | 2009-06-03 |
| Date of Event | 2009-05-01 |
| Date Mfgr Received | 2009-06-01 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2011-03-25 |
| 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 | 2009-06-04 |
| Model Number | NA |
| Catalog Number | 6326 |
| Lot Number | 193160904 |
| ID Number | NA |
| Device Expiration Date | 2014-10-01 |
| 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 | 2009-06-04 |