MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-12 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[20352328]
The doctor reported to a porex sales representative that the patient received two medpor rz mandible angles in (b) (6) 2009. The doctor stated that an infection developed in the area surrounding one of the mandible implants. The doctor stated that he treated an infection with antibiotics (clindamycin) several times. The doctor reported that the patient is doing better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2010-00006 |
| MDR Report Key | 1631294 |
| Report Source | 05 |
| Date Received | 2010-03-12 |
| Date of Report | 2010-03-10 |
| Date of Event | 2009-12-29 |
| Date Mfgr Received | 2010-02-18 |
| Date Added to Maude | 2010-03-18 |
| 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 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 | 2010-03-12 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-12 |