MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-01-27 for MEDPOR MALAR IMPLANT 9516 manufactured by Porex Surgical, Inc..
[22167440]
A malar implanted in 2000 had slipped out of place and the pt wanted a referral for a physician who could evaluate and reposition. Dr was referred and reviewed the pt. No infection or health risk existed, only a dissatisfied cosmetic result. Dr replaced this implant in 2005. He stated to porex he felt the slippage was technique related and not an implant issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2005-00008 |
| MDR Report Key | 573612 |
| Report Source | 04 |
| Date Received | 2005-01-27 |
| Date of Report | 2005-01-19 |
| Date of Event | 2005-01-13 |
| Date Added to Maude | 2005-02-18 |
| 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 | 6780479161 |
| 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 MALAR IMPLANT |
| Generic Name | FACIAL AUGMENTATION |
| Product Code | LZK |
| Date Received | 2005-01-27 |
| Model Number | 9516 |
| Catalog Number | 9516 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 563480 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 15 DART RD. NEWNAN GA 30265 US |
| Baseline Brand Name | MEDPOR MALAR IMPLANT |
| Baseline Generic Name | FACIAL AGUMENTATION |
| Baseline Model No | 9516 |
| Baseline Catalog No | 9516 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-27 |