MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-03-04 for MEDPOR IMPLANT 9553, 9536 manufactured by Porex Surgical.
[20346136]
The pt received two implants, a regular nasal shell and a nasal sheet in 2004. The pt appeared to be rejecting the implant immediately after it was implanted. The pt had two surgeries prior 4 months later when the implant was removed. When the implant was removed, the doctor stated that the infection appeared to be underneath the implant. The implant was cultured by the physician and the results were methicillin-resistant staphylococcus epidermidis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00013 |
| MDR Report Key | 578754 |
| Report Source | 05 |
| Date Received | 2005-03-04 |
| Date of Report | 2005-03-04 |
| Date of Event | 2004-12-01 |
| Date Mfgr Received | 2005-02-04 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2005-03-09 |
| 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 IVERSON |
| 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 | 2005-03-04 |
| Model Number | NA |
| Catalog Number | 9553, 9536 |
| Lot Number | 0051501044 |
| ID Number | * |
| Device Expiration Date | 2004-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 568602 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL RECONSTRUCTION |
| Baseline Model No | NA |
| Baseline Catalog No | 9553, 9536 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-03-04 |