BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES SKYN

    MDR report key: 3628645 · Received January 30, 2014

    Report

    Report Number
    1019632-2014-00003
    Event Type
    Injury
    Date Received
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    SURETEX LTD.
    Product Code
    MOL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT THE LIFESTYLES POLYISOPRENE LUBRICATED CONDOM SHE WAS USING BROKE AND SHE WAS NOW BEING TESTED FOR STD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66018 LIFESTYLES SKYN LUBRICATED POLYISOPRENE CONDOM MOL SURETEX LTD. 1205100222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other