MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-01-27 for MEDPOR 9536 manufactured by Porex Surgical, Inc..
[393300]
Dr. Placed a nasal implant into a pt. After the 5th day, the pt presented with a very small area of redness at the tip of the nose and exhibited pinkish/ puffiness around the eyes. Treatment with antibiotics provided no results. The pt was referred to an allergist who suggested an allergic reaction to the implant. The implant was ex-planted and replaced with septeal cartilage. 30-days follow-up indicated same redness. Physician felt reaction was pt related not implant related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00007 |
| MDR Report Key | 568875 |
| Report Source | 05 |
| Date Received | 2005-01-27 |
| Date of Report | 2005-01-15 |
| Date of Event | 2003-03-10 |
| Date Added to Maude | 2005-02-01 |
| 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 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 |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | MBS |
| Date Received | 2005-01-27 |
| Model Number | 9536 |
| Catalog Number | 9536 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 558704 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 15 DART RD. NEWNAN GA 30265 US |
| Baseline Brand Name | MEDPOR |
| Baseline Generic Name | FACIAL RECONSTRUCTION |
| Baseline Model No | 9536 |
| Baseline Catalog No | 9536 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-01-27 |