BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 9297690 · Received November 8, 2019

    Report

    Report Number
    1226572-2019-00525
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 15, 2019
    Report Date
    October 29, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    UDI-DI
    00385609600036
    PMA / PMN Number
    KI103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED 3 V-GOS FELL OFF NEARLY 2 WEEKS AGO. PATIENT STATED SHE BENT FREQUENTLY WHILE CLEANING JUST PRIOR TO THE V-GOS FALLING OFF. PATIENT STATED SHE WORE THE V-GOS FOR NEARLY 12 HOURS BEFORE THEY FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094189 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 20 VG219080B 00385609600036

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR