BEUDAMED
    FDA Adverse Event Summary report: N

    LIFESTYLES FUN BUMPS

    MDR report key: 4142589 · Received September 30, 2014

    Report

    Report Number
    1019632-2014-00014
    Date Received
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    SURETEX LTD.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT ON BEHALF OF SURETEX LTD.

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES LUBRICATED CONDOM HE AND HIS PARTNER SUFFERED AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608026 LIFESTYLES FUN BUMPS LUBRICATED LATEX CONDOM HIS SURETEX LTD. 1401170116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other