MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-30 for MEDPOR IMPLANT 9515 manufactured by Porex Surgical.
[863638]
The doctor stated that he placed medpor extended contoured left malar implant in 2008. The doctor stated that two weeks post op the patient developed an infection. The doctor stated that he treated the infection with an antibiotic. The doctor reported that he removed the implant the following month. The doctor stated that the infection has been resolved and he plans to replace the implant.
Patient Sequence No: 1, Text Type: D, B5
[8063434]
Following a review of the device history record for lot number 9515-c013h86h, it was determined that all processes and test criteria are within the medpor implant finished product specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00018 |
| MDR Report Key | 1054632 |
| Report Source | 05 |
| Date Received | 2008-05-30 |
| Date of Report | 2008-05-29 |
| Date of Event | 2008-04-14 |
| Date Mfgr Received | 2008-05-02 |
| Device Manufacturer Date | 2007-08-10 |
| Date Added to Maude | 2009-05-12 |
| 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 ROAD |
| 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 | 2008-05-30 |
| Model Number | NA |
| Catalog Number | 9515 |
| Lot Number | C013H86H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-30 |