BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8874804 · Received August 8, 2019

    Report

    Report Number
    1226572-2019-00286
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 2, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT DUE TO HER SWEATING THE V-GO IS NOT ADHERING TO HER SKIN. PATIENT IS PROPERLY CLEANING THE SITE BEFORE APPLYING THE V-GO. SHE PLACES THE V-GO ON HER LEFT SIDE. DUE TO THE V-GO NOT ADHERING PATIENT MENTIONED THAT THE NEEDLE WOULD HURT AND POKE HER. PATIENT WOULD REMOVE AND REPLACE WITH A NEW V-GO. THE PATIENT STATED THAT SHE EXPERIENCED THIS OVER 9 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668790 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR