BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10293564 · Received July 19, 2020

    Report

    Report Number
    1226572-2020-00244
    Event Type
    Malfunction
    Date Received
    July 19, 2020
    Date of Event
    July 3, 2020
    Report Date
    July 15, 2020
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    UDI-DI
    00385609400032
    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 WIFE REPORTED THAT IN THE PAST 10 TO 14 DAYS 9 V-GO 20'S HAVE BEEN LOST DUE TO THE ADHESIVE PAD NOT STAYING ATTACHED TO THE BODY. WIFE REPORTED FOLLOWING PROPER PREOPERATIVE PROCEDURE AND THE V-GO IS STILL BECOMING LOSE USUALLY AFTER 10 TO 12 HOURS OR A FULL DAY OF WEAR. V-GO DEVICES WERE DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757854 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 20 VG219213B 00385609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR