BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 9297372 · Received November 8, 2019

    Report

    Report Number
    1226572-2019-00513
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THAT V-GO IS FALLING OFF DUE TO SWEAT. PATIENT STATED HE WEARS V-GO ABOVE HIS WAIST BECAUSE HE CRAWLS INTO SMALL SPACES FOR WORK. PATIENT STATED HE HAS USED DUCK TYPE TO KEEP V-GO ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095820 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR