MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-05 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[20616102]
A doctor forwarded porex surgical an email that he had received from the father of a patient that had been referred to him by another doctor. The email which was dated august 8, 2006 stated that the patient had been born with hemi facial microtia 2006 underwent surgery for jaw distraction and the implantation of a medpor ear implant. The doctor took skin grafts from behind the neck and the underside of both arms of the patient to cover the ear implant. The email stated that the surgery took eleven hours and that the doctor was satisfied with the results. On the eighth day after the surgery, the father notcied that the large skin graft on the top of the ear had blackened. Approx after 2 months, the skin graft fell off and the medpor implant was exposed. The doctor removed the medpor ear implant 34 days later. The doctor then referred the patient to the doctor who reported the incident that this mdr is reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2006-00014 |
| MDR Report Key | 767894 |
| Report Source | 05 |
| Date Received | 2006-10-05 |
| Date of Report | 2006-10-05 |
| Date of Event | 2006-09-11 |
| Date Mfgr Received | 2006-09-19 |
| Date Added to Maude | 2006-10-11 |
| 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 RD |
| 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 | 2006-10-05 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 755781 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-05 |