BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 15815002 · Received November 17, 2022

    Report

    Report Number
    1226572-2022-00172
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    September 1, 2022
    Report Date
    November 2, 2022
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400018
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT STATED THAT WHEN HE WAS IN THE PHILIPPINES IT WAS VERY HOT, WHICH CAUSED HIM TO PERSPIRE ON HIS STOMACH. THIS IS WHERE THE V-GO IS ATTACHED. HE HAD TO USE 2 OF THEM ON ABOUT 18 TO 20 DIFFERENT DAYS, BECAUSE OF LOSS OF ADHESION AND THE DEVICES FELL OFF. THE DEVICES ARE NOT AVAILABLE FOR RETURN BECAUSE THEY WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2829846 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 40 FG421088 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male