MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-10-01 for MEDPOR IMPLANT 84012 manufactured by Porex Surgical.
[20943142]
The doctor reported to a distributor that the patient received a medpor nasal implant in 2009. The doctor stated that the surgery was for reconstruction of the nasal septum. The doctor stated that the implant was cut to shape and implanted. The doctor stated that "the intervention" was a lot less extensive thanks to the implant so that the planned hospitalization is not necessary". The doctor stated that he would remove the suture in one week and due to the small incision, implant securing is a lot more probable. The doctor stated that in 2009, a foreign body reaction in the nasal dorsum area occurred. The doctor stated that the implant extruded through the skin. The doctor reported that he removed the medpor nasal implant and placed a polyethylene placeholder. The doctor stated that the patient is satisfied with the results.
Patient Sequence No: 1, Text Type: D, B5
[21194511]
Following a review of the device history record for lot number 84012-c417k12, it was determined that all processes and test criteria are within the medpor implant finished product specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2009-00010 |
| MDR Report Key | 1491277 |
| Report Source | 05,08 |
| Date Received | 2009-10-01 |
| Date of Report | 2009-09-28 |
| Date of Event | 2009-03-09 |
| Date Mfgr Received | 2009-09-02 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2009-10-13 |
| 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 | FACIAL RECONSTRUCTION |
| Product Code | EPP |
| Date Received | 2009-10-01 |
| Model Number | NA |
| Catalog Number | 84012 |
| Lot Number | C417K12 |
| ID Number | NA |
| 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 | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-10-01 |