BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10364227 · Received August 4, 2020

    Report

    Report Number
    1226572-2020-00266
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 28, 2020
    Report Date
    July 28, 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

    THE PATIENT REPORTED THAT THE V-GO IS FALLING OFF. THE PATIENT INDICATED THAT THIS IS NOT RELATED TO EXCESSIVE MOVEMENTS OR EXERCISES. THE PATIENT MENTIONED HE HAS BEEN USING V-GO FOR APPROXIMATELY 1 1/2 YEARS. THE PATIENT IS WEARING THE V-GO ON HIS ABDOMEN. THE PATIENT MENTIONED THAT THE V-GO FELL OFF AFTER 13 HOURS AT NIGHT TIME WHILE HE IS TAKING A BATH. THE PATIENT INDICATED THAT HE CLEANS THE AREA PROPERLY AND HE DOES NOT TOUCH THE ADHESIVE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825200 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR