MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-10-15 for MEDPOR IMPLANT 389020 manufactured by Porex Surgical.
[14929062]
The porex surgical distributor stated that she received a call from the doctor who stated that the implant did not fit properly.
Patient Sequence No: 1, Text Type: D, B5
[15170836]
The device history records for lot number 389020-mci-502-09 e017m127h were reviewed and all processes and test criteria are within the mepdor implant specification. No further info could be obtained from the doctor after several attempts.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00035 |
| MDR Report Key | 1880526 |
| Report Source | 08 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-10-07 |
| Date Mfgr Received | 2010-06-10 |
| Device Manufacturer Date | 2009-11-18 |
| Date Added to Maude | 2012-03-13 |
| 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 | MEDPOR CUSTOMIZED SURGICAL IMPLANTS |
| Product Code | JOF |
| Date Received | 2010-10-15 |
| Model Number | NA |
| Catalog Number | 389020 |
| Lot Number | MCI50209 E017M127H |
| 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 | 2010-10-15 |