BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 9739627 · Received February 21, 2020

    Report

    Report Number
    1226572-2020-00059
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    January 1, 2020
    Report Date
    February 18, 2020
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PATIENT STARTED V-GO 40 IN (B)(6) 2020 AND REPORTS THE V-GO IS APPLIED TO THE BACK OF THE ARM OR THE SIDE OF HER LEGS AND THERE WERE 4 SEPARATE OCCASIONS WHERE THE V-GO WAS NOT STICKING AND CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203638 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 40 FG420006

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR