MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-03 for MEDPOR IMPLANT 80018 manufactured by Porex Surgical.
[18913861]
The doctor reported that he performed an enucleation and placed a medpor sst sphere implant and a porex conformer. The doctor stated that at the time of the surgery, there appeared to be an infection in the pt's socket. The doctor treated the infection with antibiotics and placed the medpor sst sphere implant. The doctor stated that some time later, the pt presented with an exposure of the implant through the anterior covering tissues. The doctor repaired the exposure with donor sclera patch and infiltrated the eye with antibiotics. The doctor did not place the porex conformer during the repair. Some time later, the pt presented again with another exposure. The doctor stated that it appeared that the socket looked infected. The doctor referred the pt to another surgeon for removal and replacement of the implant. The surgeon that the pt was referred to reported that the pt was demonstrated to have an mrsa infection, and he removed the medpor sst sphere implant and placed a dermis fat graft. The surgeon reported that the pt's socket is healing and he will be placing a new prosthesis in about a month.
Patient Sequence No: 1, Text Type: D, B5
[18995381]
During the post sterilization check of the biological indicator, a positive result was noted. Attached is the system process summary, the biological indicator sterility test report, sterility investigation report, the test nonconformance record, and a letter from the contract sterilizer summarizing the nonconformance and the results. Based on the information gather from the investigation performed by the contract sterilizer, the positive result occurred after sterilization had been performed. The product in this sterility load were released by quality assurance. A copy of the current medpor instructions for use is enclosed with contraindications highlighted. Additional catalog # 80024, lot # 002020405, expiration date 04/2007. Add'l device mfr date: 04/2005. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00013 |
| MDR Report Key | 923031 |
| Report Source | 05 |
| Date Received | 2007-10-03 |
| Date of Report | 2007-08-31 |
| Date Mfgr Received | 2007-08-02 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2007-10-10 |
| 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 | 2007-10-03 |
| Model Number | NA |
| Catalog Number | 80018 |
| Lot Number | A141M24 |
| ID Number | NA |
| Device Expiration Date | 2015-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 896172 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-03 |