MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-29 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[653879]
The dr placed two medpor ear implants (ear rim and base) in 2006. The medpor ear rim implant became exposed by the first mo. The dr repaired the exposed area of the implant but in 2007, the dr stated, that she removed the ear rim implant. The dr stated, that she did not use the correct technique and that the pt did not follow the post-op instructions. The dr stated, that with the help of another surgeon familiar with the technique, she would replace the ear rim implant at another date. The pt is doing well at this time.
Patient Sequence No: 1, Text Type: D, B5
[7874023]
In the past two years, we manufactured 1593 pieces and distributed 1483 pieces of the ear rim implants. Of the 1483 pieces distributed, the complaint percentage rate for the past two yrs is. 0026. We have had three other incidences concerning exposed ear rim implants. The mdr reporting #'s are 1057129-2006-0014, 1057129-2007-0001 and 1057129-2007-0008. A copy of the current instructions for use is enclosed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00009 |
| MDR Report Key | 857508 |
| Report Source | 05 |
| Date Received | 2007-05-29 |
| Date of Report | 2007-05-24 |
| Date of Event | 2007-04-17 |
| Date Mfgr Received | 2007-04-23 |
| Date Added to Maude | 2007-06-05 |
| 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 | 0 |
| 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 |
| 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 | 2007-05-29 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 842657 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-29 |