BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10560758 · Received September 21, 2020

    Report

    Report Number
    1226572-2020-00325
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 25, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609600012
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS THAT SHE WAS TRAINED BY A V-GO REPRESENTATIVE THIS MORNING AND AFTER TWO HOURS OF USE ADHESIVE PAD DID NOT STAY ATTACHED TO THE BODY. PATIENT CONFIRMS THAT PROPER SITE PREPARATION WAS COMPLETED AND THERE WAS NO INCREASED MOVEMENT OR INTERFERENCE WITH CLOTHING. PATIENT WAS WEARING THE V-GO ON HER ABDOMEN WHEN IT FELL OFF. PATIENT IS A FORMER SURGICAL NURSE AND BELIEVES THAT THE WEIGHT OF THE FILLED V-GO IS TOO MUCH FOR THE TYPE OF ADHESIVE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026386 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 40 FG420047 00385609600012

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR