MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-15 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical.
[16922172]
The doctor's office coordinator stated that they received a left and right medpor customized malar implants that were mislabeled. The coordinator stated that the incident did not increase surgery time and did not cause any delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2010-00024 |
| MDR Report Key | 1880518 |
| Report Source | 05 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-08-10 |
| Date Mfgr Received | 2010-06-07 |
| Device Manufacturer Date | 2010-01-01 |
| 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 | 89021 |
| 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 |