BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10364234 · Received August 4, 2020

    Report

    Report Number
    1226572-2020-00265
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 27, 2020
    Report Date
    July 28, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609400018
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VISITING NURSE FOR THE PATIENT CALLED TO REPORT THAT THE PATIENT IS LOSING MULTIPLE V-GO'S PER MONTH DUE TO VARIOUS ISSUES. THE PATIENT IS EXPERIENCING ISSUES WITH THE ADHESIVE PAD NOT STAYING ATTACHED TO THE BODY. PATIENT WEARS HER V-GO ON HER ABDOMEN AND HAS BEEN USING V-GO FOR ABOUT A YEAR. PATIENT USES PROPER PREPARATION FOR V-GO APPLICATION AND V-GO IS FREE FROM CLOTHING OR OTHER INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825542 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 40 FG420061 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR