BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIO 60 SECOND FACE LIFT TONER

    MDR report key: 3231297 · Received July 11, 2013

    Report

    Report Number
    MW5030894
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    July 11, 2013
    Product Code
    ORU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HI, I HAVE BEEN USING THE RIO 60 SECOND FACE LIFT FACIAL TONER, BY RIO, AND IT MAY HAVE CAUSED FAT ATROPHY IN MY FACE. I DID SOME RESEARCH AND I FOUND THAT THE DEVICE HAS NOT BEEN FDA APPROVED YET IT IS BEING SOLD IN (B)(4) WELL KNOWN STORES. WHY HASN'T THE PRODUCT BEEN FDA APPROVED AND IS IT SAFE TO USE. THANKS. MFR NAME: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319757 RIO 60 SECOND FACE LIFT TONER ELECTRICAL MUSCLE STIMULATOR ORU

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| S