MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-19 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[20994126]
The doctor stated that he removed a medpor custom implant from a patient that had become infected. The doctor stated that he did not do the original surgery to place the implant. The doctor informed co that the patient is mildly retarded and suffers from epilepsy and frequently has scratching fits that may have caused the suture line to open, thereby causing a partial exposure of the implant. The doctor stated that the implant was not the problem that caused the implant to be removed. The doctor stated that several months after the implant was removed, pmma was used to reconstruct the cranial vault.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00031 |
| MDR Report Key | 628501 |
| Report Source | 05 |
| Date Received | 2005-08-19 |
| Date of Report | 2005-08-19 |
| Date Mfgr Received | 2005-07-21 |
| Date Added to Maude | 2005-08-23 |
| 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 | 2005-08-19 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 618124 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-08-19 |