MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2005-09-06 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[385890]
During a post market surveillance review, a doctor completed a medpor biomaterial information card where he reported that he had removed an implant in his patient and replaced it with a medpor lower eyelid spacer implant. The doctor's office was contacted and the nurse stated that the removed implant was a medpor implant. The nurse did not state the type of medpor implant removed. Company has made four attempts to contact the doctor to gather information about the removal of the implant and as of today, company has only the response from the nurse stating that the implant was a medpor implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00035 |
| MDR Report Key | 633638 |
| Report Source | 03,05 |
| Date Received | 2005-09-06 |
| Date of Report | 2005-09-06 |
| Date Mfgr Received | 2005-08-03 |
| Date Added to Maude | 2005-09-09 |
| 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 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 | 2005-09-06 |
| 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 | U |
| Device Sequence No | 1 |
| Device Event Key | 623202 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-06 |