BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM JO

    MDR report key: 6301140 · Received February 3, 2017

    Report

    Report Number
    1032263-2017-00002
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 1, 2016
    Report Date
    January 25, 2017
    Manufacturer
    UNITED CONSORTIUM
    Product Code
    NUC
    PMA / PMN Number
    K132954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "THE LUBRICANT WAS FINE WHEN I USED IT EXTERNALLY BUT BURNED WHEN USED INTERNALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83072 SYSTEM JO PERSONAL LUBRICANT NUC UNITED CONSORTIUM 26145

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other