BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 9166616 · Received October 8, 2019

    Report

    Report Number
    1226572-2019-00402
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 15, 2019
    Report Date
    September 16, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THAT HER V-GO IS NOT STICKING GOOD TO HER SKIN. PATIENT STATED THAT HER V-GO FELL OFF WHILE SHE WAS IN CHURCH. PATIENT SAID THAT SHE ALWAYS PROPERLY PREPPED HER SITE. SHE STATED THAT SHE DISCARDED THE V-GO IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959572 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR