BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM JO

    MDR report key: 6355139 · Received February 23, 2017

    Report

    Report Number
    1032263-2017-00005
    Event Type
    Injury
    Date Received
    February 23, 2017
    Report Date
    February 23, 2017
    Manufacturer
    UNITED CONSORTIUM
    Product Code
    NUC
    PMA / PMN Number
    K150480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CAUSED BURNING AND INFECTION TO REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135228 SYSTEM JO PERSONAL LUBRICANT NUC UNITED CONSORTIUM 153675

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention