BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 10701126 · Received October 19, 2020

    Report

    Report Number
    1226572-2020-00384
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 2, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE EVALUATION RESULTS ARE AS FOLLOWS: THE COMPLAINT ABOUT THE DEVICE FELL OFF EVENT COULD NOT BE CONFIRMED. THERE WAS CONTAMINATION OBSERVED ON THE ADHESIVE FOAM PAD, AND THE DEVICE WAS RETURNED WITH PACKAGING TAPE ATTACHED TO THE FOAM PAD. DUE TO THE CONDITION OF THE ADHESIVE PAD UPON RECEIPT, IT IS NOT POSSIBLE TO EVALUATE THE ADHESION PROPERTIES THAT WOULD RESULT TO A FALL OF THE DEVICE.

    Description of Event or Problem · 1

    PATIENT STATED V-GOS FALL OFF AFTER HE SWEATS. PATIENT STATED HE APPLIES V-GOS AT BEDTIME, BUT AFTER SWEATING, THE V-GOS FALL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166688 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 40 VG420028B 00385609400018

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR