MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-09-14 for MEDPOR IMPLANT UNK manufactured by Porex Surgical, Inc..
[429645]
The doctor stated that pt underwent surgery and he placed a medpor inferior orbital rim implant. A couple of weeks after placing the orbital rim implant, the doctor stated that the pt developed an infection. The doctor stated that the pt had pus coming from the incision site. The doctor also noted that the orbital rim implant was not extruding. The doctor explained that he treated the pt with antibiotics both pre and post surgery and in handling, the implant only touched stainless steel in the or. He also stated that he would treat the infection with antibiotic in an effect to resolve the infection and if the infection did not get better, he would explant the product. The doctor notified co that the implant was removed and the infection has resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00034 |
| MDR Report Key | 635144 |
| Report Source | 05 |
| Date Received | 2005-09-14 |
| Date of Report | 2005-09-14 |
| Date Mfgr Received | 2005-08-11 |
| Date Added to Maude | 2005-09-19 |
| 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 | 2005-09-14 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| 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 | 624700 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 15 DART RD NEWNAN GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-09-14 |