BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 11655599 · Received April 13, 2021

    Report

    Report Number
    1226572-2021-00147
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    April 4, 2021
    Report Date
    April 7, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609600036
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THAT THE ADHESIVE IS NOT STICKING TO PATIENT ARM. PATIENT STATED THAT EVERY TIME THE V-GO IS APPLIED ON PATIENT ARM IT FALLS OFF. PATIENT IS NOW APPLYING THE V-GO DEVICE TO HER ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554653 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 20 VG220122B 00385609600036

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR