MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-20 for MEDPOR IMPLANT 9536 manufactured by Porex Surgical.
[19900849]
The doctor stated that the pt received a medpor nasal sheet implant in 2005 in a septoplasty procedure. The doctor reported that the implant was removed in 2006 because of rejection. The doctor stated that during the removal surgery the same month, he placed another medpor nasal sheet implant. The doctor reported that the patient developed an infection and rejection three months later, and he removed the other medpor nasal sheet implant and treated the patient with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[20113751]
Following a review of the device history record for lot 9536-a201d09 and lot 9536-b109b04, it was determined that all processes and test criteria are within the medpor implant finished product specification. Additional device lot #: b109b04; date of mfr: 03/2006. Additional implant date: 2006; additional explant date: 2006
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00006 |
| MDR Report Key | 1017129 |
| Report Source | 05 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-13 |
| Date of Event | 2006-07-01 |
| Date Mfgr Received | 2008-02-12 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2009-05-01 |
| 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 |
| 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 | 2008-03-20 |
| Model Number | NA |
| Catalog Number | 9536 |
| Lot Number | A201D09 |
| 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 ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-20 |