BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10184776 · Received June 23, 2020

    Report

    Report Number
    1226572-2020-00181
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    May 26, 2020
    Report Date
    May 29, 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 THE 1ST V-GOS APPLIED ON (B)(6) 2020 FELL OFF LESS THAN AN HOUR AFTER BEING APPLIED. PATIENT PROPERLY PREPARED SITE FOR APPLICATIONS, THAT NO SWEATING NOR INTERFERENCE WITH CLOTHING WERE REPORTED. PATIENT STATED THAT V-GOS WORN PRIOR TO (B)(6) 2020 WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649194 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 35 YR