MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-16 for MEDPOR IMPLANT 6330 manufactured by Porex Surgical.
[386927]
The doctor stated that he performed rhinoplasty on his patient and placed a medpor sheet implant. Prior to surgery the doctor stated the he partly removed and shaped the rib cartilage. The doctor stated that an autologous rib cartilage implant was removed during the primary procedure. The doctor also performed a functional microscopic sinus surgery on this patient during this surgery. The doctor stated that the implant was partially uncovered from the intranasal tissue and the uncovered parts of the implant was removed two times. The doctor stated that the removed implant had no indication of infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00033 |
| MDR Report Key | 627777 |
| Report Source | 05 |
| Date Received | 2005-08-16 |
| Date of Report | 2005-08-15 |
| Date of Event | 2005-08-11 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2005-08-19 |
| 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 |
| 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 | 2005-08-16 |
| Model Number | NA |
| Catalog Number | 6330 |
| Lot Number | A004B04 |
| ID Number | * |
| Device Expiration Date | 2015-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 617408 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL RECONSTRUCTION |
| Baseline Model No | NA |
| Baseline Catalog No | 6330 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-08-16 |