BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JO H2O COOLING PERSONAL LUBRICANT

    MDR report key: 6594221 · Received May 26, 2017

    Report

    Report Number
    1032263-2017-00009
    Event Type
    Injury
    Date Received
    May 26, 2017
    Report Date
    May 26, 2017
    Manufacturer
    UNITED CONSORTIUM
    Product Code
    NUC
    UDI-DI
    00796494402078
    PMA / PMN Number
    K150480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER CUSTOMER - "EVERY TIME WE USED THIS MY WIFE WOULD END UP WITH VERY IRRITATED SKIN AND SOMETIMES A UTI."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375699 JO H2O COOLING PERSONAL LUBRICANT PERSONAL LUBRICANT NUC UNITED CONSORTIUM 40209 11046 00796494402078

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other