MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-09 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[22047912]
Item and lot number not provided to allow for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[22127172]
The doctor stated that the patient received a medpor plus implant. The doctor stated that the implant was doing well, but a need for further surgeries for orbital malignancy meant that the implant had to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2010-00009 |
| MDR Report Key | 1659087 |
| Report Source | 05 |
| Date Received | 2010-04-09 |
| Date of Report | 2010-04-08 |
| Date Mfgr Received | 2010-03-22 |
| Date Added to Maude | 2012-02-28 |
| 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 INERSEN |
| 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 | JAZ |
| Date Received | 2010-04-09 |
| Model Number | NA |
| Catalog Number | UNK |
| 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 | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-09 |