MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-03 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[716302]
The doctor reported that his pt developed an infection in the chin area. The doctor stated that he removed the medpor chin implant in pieces. The doctor stated that after he removed the implant, the pt continues to have an infection in the area and he has been unable to find the source of the infection. The doctor called inquiring about a study that would allow residual pieces of the implant to be seen through an mri, ct scan or other device. The incident coordinator referred the doctor to a consultant who has experience with implantation and removal of the medpor chin implant.
Patient Sequence No: 1, Text Type: D, B5
[7857583]
The doctor did not provide item and lot number information. In the past 30 months, we manufactured and distributed total pieces of the chin implants. Of the pieces distributed. A copy of the article by dr. Michael yaremchuk, md entitled "improving aesthetic outcomes after alloplastic chin augmentation" is enclosed. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00012 |
| MDR Report Key | 923032 |
| Report Source | 05 |
| Date Received | 2007-10-03 |
| Date of Report | 2007-09-26 |
| Date Mfgr Received | 2007-08-02 |
| Date Added to Maude | 2007-10-10 |
| 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 | 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 | LZK |
| Date Received | 2007-10-03 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 896167 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-03 |