BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 15426554 · Received September 15, 2022

    Report

    Report Number
    1226572-2022-00129
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 9, 2022
    Report Date
    August 17, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE COMPLAINT REGARDING THE DEVICE FELL OFF EVENT. DEVICE #052325-A WAS INSPECTED. DUE TO THE USED CONDITION OF THE FOAM POD, THE ORIGINAL ADHESIVE PROPERTIES COULD NOT BE VERIFIED. THE COMPLAINT FOR THIS DEVICE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    A PATIENT RETURNED ONE V-GO 40 DEVICE WITH THE DEVICE LABELED AS "FELL OFF". NO ADDITIONAL DETAILS SURROUNDING THE EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522319 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 40 FG421102 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male