BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8944196 · Received August 29, 2019

    Report

    Report Number
    1226572-2019-00318
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 13, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT FOUR V-GOS, WORN ON THE ABDOMEN, FELL OFF AFTER BEING WORN FOR ABOUT FOUR TO FIVE HOURS. PATIENT SAID THEY WERE ALL FROM THE SAME BOX AND THIS HAS HAPPENED BEFORE BUT ONLY ONCE. PATIENT SAID SHE COULD NOT GIVE ANY PARTICULAR REASON WHY THIS HAPPENED EXCEPT THAT SHE FEELS IT MAY BE THAT THERE MAY NOT HAVE BEEN ENOUGH ADHESIVE ON THE PADS. PATIENT DID NOT HAVE ANY OF THE V-GOS THAT FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737810 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR