MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-16 for MEDPOR IMPLANT 157030404 manufactured by Porex Surgical.
[21700418]
The doctor stated, that he placed a medpor nasal implant in 2004. The nasal implant area became infected and the implant extruded in 2006. The doctor stated, that he removed the implant, when the infection did not resolve after treatment. The doctor stated, that he replaced the implant two months later, with another medpor nasal implant of the same type. The replacement nasal implant area also became infected and the doctor removed the implant five months later. The doctor stated, that he performed a septoplasty and a tubinate reduction at the time of the primary surgery.
Patient Sequence No: 1, Text Type: D, B5
[21866600]
The doctor indicated that the implant was in good condition after it was explanted. The device history records for this lot were checked from processing to finished good and is within specification. Sterility testing was performed as required and all tests passed. In the past 24 months, we manufactured 772 pieces and distributed 691 pieces of the nasal implants and of the 691 pieces distributed, the complaint percentage rate for the past 24 months is. 0072. Enclosed is a journal article entitled "nasal reconstruction using porous polyethylene implants".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00003 |
| MDR Report Key | 829935 |
| Report Source | 05 |
| Date Received | 2007-03-16 |
| Date of Report | 2007-03-05 |
| Date of Event | 2006-02-16 |
| Date Mfgr Received | 2007-02-08 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2007-03-23 |
| 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 | 2007-03-16 |
| Model Number | NA |
| Catalog Number | 157030404 |
| Lot Number | 7546 |
| ID Number | NA |
| Device Expiration Date | 2014-04-01 |
| 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 | 817321 |
| 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 | 157030404 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-16 |