BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10096735 · Received May 28, 2020

    Report

    Report Number
    1226572-2020-00169
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 21, 2020
    Report Date
    May 21, 2020
    Manufacturer
    ZEALAND PHARMA U.S. 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

    PATIENT REPORTED THAT AT TIMES THE ADHESIVE PAD IS NOT STICKING FOR THE FULL 24 HOUR PERIOD. PATIENT STATED AT TIMES THE ADHESIVE PAD WON'T STICK IMMEDIATELY AFTER APPLYING THE VGO OR SOMETIMES FROM A FEW MINUTES TO A FEW HOURS THE ADHESIVE PAD DETACHES. PATIENT IS CLEANING THE SITE BEFORE APPLYING THE VGO AND AVOIDING FOLDED SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561755 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR