MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-29 for MEDPOR IMPLANT 81120 manufactured by Porex Surgical.
[798109]
The doctor reported, that he placed a medpor coated tear drain implant. The doctor stated, that this was his first experience with implantation of a medpor coated tear drain. The doctor stated, the procedure was uneventful, but, and at early post-op, the implant had become dislocated. Upon removal of the medpor tear drain implant, the medpor coating separated from the glass tear drain. The doctor requested information on the implantation technique for the medpor coated tear drain. The doctor was sent information, and it was suggested that if he needed additional information, he could contact a surgeon with experience using medpor coated tear drains.
Patient Sequence No: 1, Text Type: D, B5
[8044117]
The device history records were reviewed and all processes and test criteria have been verified as complying with the medpor coated tear drain implant specification. A copy of the current medpor coated tear drain instructions for use is enclosed. This document accompanies each medpor coated tear drain. A copy of a power point presentation by ted wojno, m. D. Entitled "insertion of a medpor coated tear drain implant". This document was sent to the reporting doctor per his request.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00001 |
| MDR Report Key | 989080 |
| Report Source | 05 |
| Date Received | 2008-01-29 |
| Date of Report | 2008-01-28 |
| Date Mfgr Received | 2007-12-24 |
| Device Manufacturer Date | 2006-10-12 |
| Date Added to Maude | 2008-02-06 |
| 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 | JAZ |
| Date Received | 2008-01-29 |
| Model Number | NA |
| Catalog Number | 81120 |
| Lot Number | B005K113H |
| ID Number | NA |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 959613 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-29 |