BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10454915 · Received August 26, 2020

    Report

    Report Number
    1226572-2020-00315
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 21, 2020
    Report Date
    August 21, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609600029
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THEE PATIENT STATED THE V-GOS WERE ARE STICKING TO HER ABDOMEN, SHE CHANGED TO HER ARMS, PATIENT ESTIMATED THAT ABOUT FOUR OR FIVE V-GOS FELL OFF HER ABDOMEN, ON AVERAGE AFTER BEING ON FOR ABOUT EIGHT HOURS. THE PATIENT HAD A RASH THAT DEVELOPED INTO BLISTERS AND RED WELTS. THE PATIENT HAS BEEN ON THE V-GO SINCE (B)(6) OF 2013 AND THIS IS THE FIRST TIME SHE HAS HAD THIS PROBLEM. PATIENT THINKS THEY FELL OFF BECAUSE OF THE BLISTERS AND WELTS ON HER ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918716 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 30 VG319223B 00385609600029

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR