BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 11222880 · Received January 25, 2021

    Report

    Report Number
    1226572-2021-00018
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    December 1, 2020
    Report Date
    January 15, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    385609600036
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    SPOUSE STATED V-GOS LOOSENED AND SOME FELL OFF DURING DECEMBER 2020. SPOUSE DID NOT PROVIDE SPECIFIC DATES OR DETAILS FOR THOSE EVENTS AND THOSE V-GOS WERE DISCARDED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118302 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 20 VG219262B 385609600036

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR