MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-06-23 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical.
[21283664]
The doctor stated that the pt received a medpor customized surgical implant. The doctor reported that the pt developed an infection and the implant was removed. The doctor reported that the infection was not caused by the implant and the pt is fine. The doctor stated that he will replace the implant with another medpor implant when the implant is available.
Patient Sequence No: 1, Text Type: D, B5
[21323787]
Following a review of the device history record for lot number 89021-mci-059-10 f012b15h, 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 | 1057129-2010-00014 |
| MDR Report Key | 1736730 |
| Report Source | 05,08 |
| Date Received | 2010-06-23 |
| Date of Report | 2010-06-23 |
| Date Mfgr Received | 2010-05-25 |
| Device Manufacturer Date | 2010-02-10 |
| Date Added to Maude | 2010-06-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDPOR CUSTOMIZED SURGICAL IMPLANT |
| Product Code | JOF |
| Date Received | 2010-06-23 |
| Model Number | NA |
| Catalog Number | 89021 |
| Lot Number | MCI059-10 F012B15H |
| ID Number | 510K #K083621 |
| 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 | 2010-06-23 |