BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 9131510 · Received September 27, 2019

    Report

    Report Number
    1226572-2019-00384
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    September 7, 2019
    Report Date
    September 7, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT AS SHE WORE THE V-GO THE NEEDLE WOULD CONSISTENTLY SLIDE OUT. PATIENT PLACED THE V-GO ON HER UPPER STOMACH. PATIENT DID MENTION AT TIMES SHE WOULD BUMP THE V-GO AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923814 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR