MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-01-19 for MEDPOR IMPLANT 8328 manufactured by Porex Surgical.
[1998102]
A doctor reported to our (b)(6) distributor that in the past two years, five of his pts had auricle reconstruction using medpor ear implants. The five pts suffered from problems with skin necrosis, local extrusions and pain. The doctor stated that he removed the implants from two of the pts. He partially removed the implants from the remaining three pts and covered the remaining portion of the implants with local skin flaps.
Patient Sequence No: 1, Text Type: D, B5
[9217797]
Add'l catalog numbers: 8328, 8329, 8329, 8330, 8330, 8330, 8331, 8331. Add'l lot numbers: a284e11a(2), 002110104h, 104160904, 142150903a, a001e11a, a002d53h, 057181103a, 023160904. Add'l expiration dates: 05/2015, 01/2014, 09/2014, 09/2013, 05/2015, 04/2015, 11/2013, 09/2014. Add'l manufacture dates: 05/2005, 01/2004, 09/2004, 09/2003, 05/2005, 04/2005, 11/2003, 09/2004. In the past two years, we manufactured 1540 pieces and distributed 1202 pieces of the ear rim implants. Of the 1202 pieces distributed, the complaint percentage rate for the past two years is. 0016. We had one incident in (b)(6) of 2006 similar to this one concerning an exposed ear rim implant. The mdr reporting number is 1057129-2006-0014. All device history records were checked from processing to finished good and all were within specification. A copy of the current instructions for use and labeling are enclosed. A paper "microtia ear reconstruction procedure" by (b)(6), m. D. , f. A. C. S. Is enclosed also.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00001 |
| MDR Report Key | 2198788 |
| Report Source | 05 |
| Date Received | 2007-01-19 |
| Date of Report | 2007-01-18 |
| Date Mfgr Received | 2006-12-20 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2011-08-10 |
| 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 | NEWMAN 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 | 2007-01-19 |
| Model Number | NA |
| Catalog Number | 8328 |
| Lot Number | 0111260804H |
| ID Number | NA |
| Device Expiration Date | 2014-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2007-01-19 |