MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-06 for MEDPOR IMPLANT 9516 manufactured by Porex Surgical.
[19149779]
The doctor stated that he has a patient with severe deficiency in the midface and paranasal areas. The doctor stated that after putting the patient under anesthesia, he examined the implant and found small pieces of medpor instead of the malar implant ordered. The doctor stted that he had to call off the surgery at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00024 |
| MDR Report Key | 620539 |
| Report Source | 05 |
| Date Received | 2005-07-06 |
| Date of Report | 2005-07-06 |
| Date of Event | 2005-06-07 |
| Date Mfgr Received | 2005-06-07 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-07-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JAZ |
| Date Received | 2005-07-06 |
| Returned To Mfg | 2005-06-09 |
| Model Number | NA |
| Catalog Number | 9516 |
| Lot Number | A110A02 |
| ID Number | * |
| Device Expiration Date | 2015-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 610224 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA * US |
| Baseline Brand Name | MEDPOR MALAR IMPLANT |
| Baseline Generic Name | FACIAL AGUMENTATION |
| Baseline Model No | 9516 |
| Baseline Catalog No | 9516 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-06 |