BEUDAMED
    FDA Adverse Event Summary report: N

    M/N: ITOVI TRACKER

    MDR report key: 7742230 · Received August 1, 2018

    Report

    Report Number
    MW5078762
    Date Received
    August 1, 2018
    Report Date
    July 19, 2018
    Manufacturer
    ITOVI
    Product Code
    GZO
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED A RECALL NOTICE FOR AN ITOVI TRACKER. (B)(4) IC:20864-TOV20021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580044 M/N: ITOVI TRACKER DEVICE GALVANIC SKIN RESPONSE MEASUREMENT GZO ITOVI IC:20864 - TOV 20021

    Patients

    Seq Age Sex Outcome Treatment
    1