MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2010-10-15 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[1689588]
A pt contacted porex surgical and stated that she received a medpor dartt implant in (b)(6) of 2009. The pt stated that she has "developed three infections in four months and cannot find anyone in her town that uses these artificial devices to help her besides the doctor that did it and she refuses to have him touch her. " the pt stated that she is on medical leave for not only infections but she also has been diagnosed with severe depression. The pt requested info on the medpor dartt implant and potential side effects. The pt gave porex surgical permission to contact the surgeon who performed the surgery. When contacted, the nurse stated that the pt would need to come into the surgeon's office and sign the release in person in order to release the info to porex surgical. The pt was informed that the releases had to be signed in person. The nurse stated that the documents were ready but the pt did not come into the office to sign the release.
Patient Sequence No: 1, Text Type: D, B5
[8919032]
No additional info was received from the pt or surgeon to substantiate the case for further eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00023 |
| MDR Report Key | 1880542 |
| Report Source | 04,06 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-08-10 |
| Date Mfgr Received | 2010-02-08 |
| Date Added to Maude | 2012-03-13 |
| 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 CUSTOMIZED SURGICAL IMPLANT |
| Product Code | JOF |
| Date Received | 2010-10-15 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2010-10-15 |