BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8991766 · Received September 11, 2019

    Report

    Report Number
    1226572-2019-00328
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 19, 2019
    Report Date
    August 19, 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 REPORTED THAT HIS V-GO IS CONTINUALLY FALLING OFF FROM THE BACK OF HIS ARM. PATIENT STATED THAT HE PUT TAPE TO HOLD THE V-GO ON TO HIS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788951 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR