MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-02-22 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[16364530]
The attorney stated that the pt has underwent an enucleation to the left socket in which an unwrapped medpor implant was placed. The attorney stated that the pt suffered chronic pain for approx two years and severe breakdown of the conjunctiva and tendons and exposure of the implant. The attorney stated that pt was no longer able to wear prosthesis and a secondary surgery was performed in 2005. During the secondary surgery, the surgeon removed an unwrapped medpor implant and placed a wrapped medpor implant with banked scales and abdominal fat tissue placed in the socket.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2006-00002 |
| MDR Report Key | 678670 |
| Report Source | 00 |
| Date Received | 2006-02-22 |
| Date of Report | 2006-02-13 |
| Date of Event | 2005-07-13 |
| Date Mfgr Received | 2006-01-23 |
| Date Added to Maude | 2006-02-27 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2006-02-22 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 667937 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-02-22 |