MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-08 for MEDPOR IMPLANT 80014 manufactured by Porex Surgical.
[18613224]
The doctor stated that the pt received a medpor sst sphere implant in (b)(6) 2009. The doctor stated that at approx four week post op, during a follow-up exam, it was noticed that the implant had exposed. The doctor reported that in (b)(6) 2009, the medpor implant was not removed and the exposure of the implant was patched using (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18697588]
Following a review of the device history record for lot number 80014-d232m11, it was determined that all processes and test criteria are within the medpor implant finished product spec.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2009-00005 |
| MDR Report Key | 1413817 |
| Report Source | 05 |
| Date Received | 2009-07-08 |
| Date of Report | 2009-07-08 |
| Date of Event | 2009-03-13 |
| Date Mfgr Received | 2009-06-08 |
| Device Manufacturer Date | 2008-12-13 |
| 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 |
| 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 | 2009-07-08 |
| Model Number | NA |
| Catalog Number | 80014 |
| Lot Number | D232M11 |
| 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 | 2009-07-08 |