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 7518 manufactured by Porex Surgical.
[1237944]
The doctor reported to a porex distributor that the patient received a medpor nasal implant in 2009. The doctor stated that the surgery was for cosmetic rhinoplasty with nasal tip reconstruction and nasal dorsum reconstruction. The doctor stated that the implant was cut to shape and implanted. The doctor stated that "it was an extraordinarily difficult nasal surgical intervention which showed a satisfactory result although it will not be perfect even after optimal correction in the nasal area due to the orange peel skin". The doctor reported that five months later, in spite of correct implant placement, "the implant was rejected by the body" and the implant was removed.
Patient Sequence No: 1, Text Type: D, B5
[8367474]
Following a review of the device history record for lot numbers 7518-006680403h, 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 | 1057129-2009-00009 |
| MDR Report Key | 1491282 |
| Report Source | 05,08 |
| Date Received | 2009-10-01 |
| Date of Report | 2009-09-27 |
| Date of Event | 2009-08-03 |
| Date Mfgr Received | 2009-09-02 |
| Device Manufacturer Date | 2003-04-01 |
| 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 ROAD |
| 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 | JOF |
| Date Received | 2009-10-01 |
| Model Number | NA |
| Catalog Number | 7518 |
| Lot Number | 006680403H |
| ID Number | NA |
| Device Expiration Date | 2013-04-28 |
| 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 ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-10-01 |