MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-11 for MEDPOR EXTERNAL EAR IMPLANT * 7528 manufactured by Porex Surgical, Inc..
[56056]
Pt is status post 70% 3rd degree burn on 6/5/89. As a result of the burn, pt lost right ear. Staged reconstruction of right external ear begun with implant of med-por external ear surgical implant on 2/7/97. Pt did well until 4/29/97 when exposure of tips of the graft was reported without signs of infection or cellulitis. The implant was removed at surgery on 4/30/97.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011456 |
| MDR Report Key | 97350 |
| Date Received | 1997-06-11 |
| Date of Report | 1997-05-15 |
| Date of Event | 1997-04-30 |
| Date Added to Maude | 1997-06-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR EXTERNAL EAR IMPLANT |
| Generic Name | EXTERNAL EAR IMPLANT |
| Product Code | FZD |
| Date Received | 1997-06-11 |
| Model Number | * |
| Catalog Number | 7528 |
| Lot Number | 182040396 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 96077 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 4715 ROSEBELT HWY COLLEGE PARK GA 303492417 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-11 |