BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOVI SCANNER

    MDR report key: 7697636 · Received July 17, 2018

    Report

    Report Number
    MW5078433
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 13, 2018
    Manufacturer
    ITOVI, LLC
    Product Code
    GZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPANY IS RECALLING ITOVI SCANNER AS THERE HAVE BEEN SOME REPORTS OF ELECTRICAL SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536738 ITOVI SCANNER DEVICE, GALVANIC SKIN RESPONSE GZO ITOVI, LLC ITS15 092017

    Patients

    Seq Age Sex Outcome Treatment
    1