MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-07-29 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[21650371]
The doctor stated to a porex surgical distributor that the pt received medpor helical rim and ear base implants. The doctor stated that the implants became exposed. The doctor contacted a surgeon who has many years of experience with medpor implant placement and removal.
Patient Sequence No: 1, Text Type: D, B5
[21863847]
After several attempts, we have been unable to reach the doctor since the initial report of the incident. Item and lot number information was not provided to complete an investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2009-00008 |
| MDR Report Key | 1425655 |
| Report Source | 08 |
| Date Received | 2009-07-29 |
| Date of Report | 2009-07-27 |
| Date Mfgr Received | 2009-06-22 |
| Date Added to Maude | 2009-08-05 |
| 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 | JAZ |
| Date Received | 2009-07-29 |
| 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 | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-29 |