MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-04 for MEDPOR IMPLANT 9514 manufactured by Porex Surgical, Inc..
[827387]
The doctor reported to a porex distributor that the pt received left and right medpor malar implants. The doctor initially stated that the area where the right medpor malar was placed showed signs of redness and clear pus. The nurse later reported that the area where the left and right medpor malar implants were placed became infected, and the doctor removed both implants.
Patient Sequence No: 1, Text Type: D, B5
[8002619]
Following a review of the device history record for lot numbers 9514-c492h10 and 9513-b190k17a it was determined that all processes and test criteria are within the medpor implant finished product specification. Add'l cat# 9513, add'l lot# b190k17a, add'l exp date: 11/2016. Add'l device mfr date: 11/2006.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00013 |
| MDR Report Key | 1026797 |
| Report Source | 05 |
| Date Received | 2008-04-04 |
| Date of Report | 2008-04-04 |
| Date of Event | 2008-02-28 |
| Date Mfgr Received | 2008-03-05 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-04-15 |
| 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 | 2008-04-04 |
| Model Number | NA |
| Catalog Number | 9514 |
| Lot Number | C492H10 |
| ID Number | NA |
| Device Expiration Date | 2017-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 994352 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-04 |