MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-07-06 for MEDPOR IMPLANT 80004 manufactured by Porex Surgical.
[484269]
The nurse reported that in 2006, a pt had an enucleation of the left eye and a 20 mm medpor sphere implant was placed. The nurse stated that the medpor sphere implant became exposed and was removed approx 2 months later.
Patient Sequence No: 1, Text Type: D, B5
[7785323]
The device history records for this lot were checked from processing to finished goods product and is within specification. Sterility testing was performed as required and all test passed. There is no evidence to support device failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2006-00009 |
| MDR Report Key | 732844 |
| Report Source | 05 |
| Date Received | 2006-07-06 |
| Date of Report | 2006-06-29 |
| Date of Event | 2006-05-18 |
| Date Mfgr Received | 2006-06-19 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2006-07-12 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2006-07-06 |
| Model Number | NA |
| Catalog Number | 80004 |
| Lot Number | A001M137H |
| ID Number | NA |
| Device Expiration Date | 2015-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 721149 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL RECONSTRUCTIVE |
| Baseline Model No | NA |
| Baseline Catalog No | 80004 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-07-06 |