BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8991755 · Received September 11, 2019

    Report

    Report Number
    1226572-2019-00344
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 23, 2019
    Report Date
    August 23, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    UDI-DI
    00385609400018
    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 THE V-GO IS FALLING OFF AFTER SHE APPLIED ON HER ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788621 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 40 VG419007B 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR