BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 8896486 · Received August 15, 2019

    Report

    Report Number
    1226572-2019-00303
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 18, 2019
    Report Date
    August 8, 2019
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT 3 V-GOS APPLIED WITHIN THE LAST 3 WEEKS HAVE FALLEN OFF. PATIENT STATED THE V-GOS FELL OFF, WITHIN 2.5 HOURS AFTER SWEATING WHILE WORKING OUTSIDE. PATIENT STATED HE DISCARDED THOSE V-GOS THAT SAME DAY. PATIENT DID NOT PROVIDE SPECIFIC DATES FOR THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690312 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR