MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-05-14 for MEDPOR IMPLANT 83007 manufactured by Porex Surgical.
[15218005]
The dr stated the pt received left and right medpor mid-face contour implants in 2007. The dr stated that the procedure was performed intra orally and the implants were covered during insertion. The dr reported that a short time after the surgery, the pt decided that he wanted the medpor mid-face rim implant replaced and requested that the dr remove the medpor mid-face contour implants. The dr stated that he felt honor obliged to proceed with the surgery. Upon removal of the left mid-face contour implant, the dr noted that there was an infection in the area. The dr stated that a swab was taken of the pus at that time, and there were no significant pathogens. The dr reported that the wound healed satisfactorily after two and a half weeks. The dr reported that the pt is in good condition.
Patient Sequence No: 1, Text Type: D, B5
[15567423]
Following a review of the device history record for lot number 83007-c304a02, it was determined that all processes and test criteria are within the medpor implant finished product spec.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00014 |
| MDR Report Key | 1045762 |
| Report Source | 08 |
| Date Received | 2008-05-14 |
| Date of Report | 2008-05-13 |
| Date of Event | 2008-01-10 |
| Date Mfgr Received | 2008-04-14 |
| Device Manufacturer Date | 2007-02-06 |
| Date Added to Maude | 2008-05-22 |
| 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 |
| 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 | 2008-05-14 |
| Model Number | NA |
| Catalog Number | 83007 |
| Lot Number | C304A02 |
| ID Number | NA |
| Device Expiration Date | 2017-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1016125 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-14 |