MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-21 for MEDPOR IMPLANT 6327 manufactured by Porex Surgical.
[20624771]
The doctor stated that the pt received a medpor sphere implant ten years ago. The doctor reported that there were small bumps of medpor that are covered by a thin layer of conjunctiva on the pt's eye. The doctor reported that he explanted the implant.
Patient Sequence No: 1, Text Type: D, B5
[20708194]
The device history records for this lot were reviewed and all processes, and test criteria are within the medpor implant specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00015 |
| MDR Report Key | 1770205 |
| Report Source | 05 |
| Date Received | 2010-07-21 |
| Date of Report | 2010-07-19 |
| Date of Event | 2010-07-02 |
| Date Mfgr Received | 2010-06-23 |
| Device Manufacturer Date | 1999-06-20 |
| Date Added to Maude | 2010-07-28 |
| 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 | MEDPOR SURGICAL IMPLANTS BLOCK FORM |
| Product Code | JOF |
| Date Received | 2010-07-21 |
| Model Number | NA |
| Catalog Number | 6327 |
| Lot Number | 108090699 |
| ID Number | 510# K832283 |
| Device Expiration Date | 2009-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-07-21 |