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 7210 manufactured by Porex Surgical.
[17761578]
The doctor stated he placed a medphor sheet implant during a septorhinoplasty procedure. The doctor stated that within 15 years the patient previously had five rhinoplasty surgeries and there was a great deal of scar tissue in the area prior to surgery. The doctor informed co that he was dissatisfied with the results of the procedure because of the large scar tissue around the implant and removed the implant. The doctor stated that after removal, the implant looked like scar tissue, fibrosis and detritus all around it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00032 |
| MDR Report Key | 627761 |
| Report Source | 05 |
| Date Received | 2005-08-16 |
| Date of Report | 2005-08-15 |
| Date of Event | 2004-11-02 |
| Date Mfgr Received | 2005-07-14 |
| Device Manufacturer Date | 2004-02-01 |
| 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 | 7210 |
| Lot Number | 048010204C |
| ID Number | * |
| Device Expiration Date | 2014-02-01 |
| 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 | 617393 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWMAN GA * US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL RECONSTRUCTION |
| Baseline Model No | NA |
| Baseline Catalog No | 7210 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-16 |