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 80002 manufactured by Porex Surgical.
[465900]
The nurse reported that in 2005, the doctor removed screws, a plate and medpor sheet implant from the pt due to an infected orbital floor. The nurse stated that in 2006, the doctor performed an evisceration and placed a 18mm medpor sphere implant in the scleral pouch. In2006, the pt also had a corneal ulcer that was infected. The infection was treated with antibiotics. The nurse stated that approx 2 months later, the medpor implant became exposed and the doctor covered it with tutoplast pericardium tissue. The pt developed an infection under the orbital floor and the medpor sphere implant was removed from the scleral pouch.
Patient Sequence No: 1, Text Type: D, B5
[7779687]
The nurse did not provide any info on the medpor sheet implant that was removed in 2005. The device history records for this lot that was reported to us was checked from processing to finished goods product and is within specification. All sterility testing was performed as required and all tests passed. There is no evidence to support device failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2006-00010 |
| MDR Report Key | 732825 |
| Report Source | 05 |
| Date Received | 2006-07-06 |
| Date of Report | 2006-06-29 |
| Date of Event | 2006-04-12 |
| 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 | 80002 |
| Lot Number | A002M137H |
| 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 | 721130 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL RECONSTRUCTION |
| Baseline Model No | NA |
| Baseline Catalog No | 80002 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-07-06 |