BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 17788739 · Received September 21, 2023

    Report

    Report Number
    1226572-2023-00105
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 31, 2023
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400018
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THE ADHESIVE OF THE V-GO IS NOT STICKING TO THEIR SKIN. THE PATIENT REPORTED THAT THE DEVICE FELL OFF AFTER A FEW HOURS OF WEAR, OR IN THE SHOWER. NO SPECIFIC EVENT DATES WERE REPORTED AND ADDITIONAL INFORMATION ON SKIN PREPARATION PRIOR TO V-GO PLACEMENT IS ALSO UNKNOWN. IT WAS REPORTED THAT NO DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986332 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 40 VG422053B 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female