BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 9218512 · Received October 22, 2019

    Report

    Report Number
    1226572-2019-00438
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    September 28, 2019
    Report Date
    September 28, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    UDI-DI
    00385609400025
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HE WORK'S CONSTRUCTION AND THE V-GO IS NOT STICKING TO HIS BODY. PATIENT STATED THAT HE ALWAYS PROPERLY PREPPED THE SITE, AND LET THE ALCOHOL DRY BEFORE HE APPLIED THE V-GO. PATIENT APPLIED THE V-GO'S IN HIS ABDOMEN AND IN THE BACK OF HIS ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015371 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 30 VG319096B 00385609400025

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR