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 7546 manufactured by Porex Surgical.
[810472]
The doctor stated that the pt received a medpor nasal dorsum and a nasal valve batten implant in (b) (6) 2006. The pt presented with an infection in (b) (6) 2007. The doctor reported that he removed the medpor nasal valve batten implant and treated the pt with antibiotics in (b) (6) 2007. The doctor stated that the patient presented with an infection in (b) (6) 2007. The doctor reported that he removed the medpor nasal dorsum implant and treated the patient with antibiotics in (b) (6) 2007.
Patient Sequence No: 1, Text Type: D, B5
[7948686]
Following a review of the device history record for lot 7546-b039g13 and lot 7516-b004c35h, it was determined that all processes and test criteria are within the medpor implant finished product specification. A non-conforming product report generated for lot 7516-b004c35h is enclosed. A copy of the current medpor instructions for use is enclosed. Additional device catalog #:7516, lot #: b004c35h, expiration date: 04/2016. Additional device manufacture date: 04/2006. Additional explant date: (b) (6) 2007.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00005 |
| MDR Report Key | 1017140 |
| Report Source | 05 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-13 |
| Date of Event | 2007-01-01 |
| Date Mfgr Received | 2008-02-12 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2009-12-30 |
| 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 | EPP |
| Date Received | 2008-03-20 |
| Model Number | NA |
| Catalog Number | 7546 |
| Lot Number | B039G13 |
| 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 |