MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-12 for MEDPOR IMPLANT 7210 manufactured by Porex Surgical.
[19964447]
The doctor reported that the pt received a medpor sheet implant in october of 2005. The doctor stated that after the surgery the pt had persistent diplopia. At 15 months after the surgery, an mri was performed and implantation cysts appeared to be around the implant. In 2007, the doctor removed the implant.
Patient Sequence No: 1, Text Type: D, B5
[20040348]
Following a review of the device history record, all process and test criteria has been verified as complying with the medpor finished goods specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00014 |
| MDR Report Key | 926908 |
| Report Source | 05 |
| Date Received | 2007-10-12 |
| Date of Report | 2007-09-26 |
| Date of Event | 2007-07-17 |
| Date Mfgr Received | 2007-09-04 |
| Device Manufacturer Date | 2005-02-04 |
| Date Added to Maude | 2007-10-18 |
| 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 RD. |
| 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 | LZK |
| Date Received | 2007-10-12 |
| Model Number | NA |
| Catalog Number | 7210 |
| Lot Number | A098A02 |
| ID Number | NA |
| Device Expiration Date | 2015-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 900369 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-12 |