BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 9198126 · Received October 16, 2019

    Report

    Report Number
    1226572-2019-00456
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    September 23, 2019
    Report Date
    September 23, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED V-GOS FALL OFF AFTER HE SWEATS. PATIENT STATED HE APPLIES V-GOS AT BEDTIME, BUT AFTER SWEATING FOR 2 HOURS AT WORK, THE V-GOS FALL OFF. PATIENT DID NOT PROVIDE SPECIFIC DATES FOR THE EVENTS. PATIENT STATED HE DISCARDED V-GOS WORN PRIOR TO TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989987 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR