MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-31 for MEDPOR IMPLANT 89020 manufactured by Porex Surgical.
[1436630]
The doctor reported that the patient received a medpor custom cranial implant in 2006 placed by another surgeon. The doctor stated that pus was on both sides of the area around the implant. The doctor stated that he drained and treated the area with antibiotics. The doctor stated that the area is "clearing up nicely. " the doctor stated that the patient is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[8660722]
The device history for 89020-mci-285-06-b004m131h was reviewed and all test criteria and processes were within specification for the medpor implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00007 |
| MDR Report Key | 1649940 |
| Report Source | 05 |
| Date Received | 2010-03-31 |
| Date of Report | 2010-03-29 |
| Date Mfgr Received | 2010-03-05 |
| Device Manufacturer Date | 2006-11-30 |
| Date Added to Maude | 2010-04-06 |
| 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 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 | 2010-03-31 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | MCI28506 B004M131H |
| 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 | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-31 |