BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JO H2O PERSONAL LUBRICANT

    MDR report key: 6477283 · Received April 10, 2017

    Report

    Report Number
    1032263-2016-00008
    Event Type
    Injury
    Date Received
    April 10, 2017
    Report Date
    April 10, 2017
    Manufacturer
    UNITED CONSORTIUM
    Product Code
    NUC
    PMA / PMN Number
    K150480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IN THE WORDS OF THE CUSTOMER, "I WAS ON FIRE WHEN USING THIS PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259771 JO H2O PERSONAL LUBRICANT PERSONAL LUBRICANT NUC UNITED CONSORTIUM 10128

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention