BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES SKYN

    MDR report key: 3372554 · Received September 10, 2013

    Report

    Report Number
    1019632-2013-00019
    Event Type
    Injury
    Date Received
    September 10, 2013
    Report Date
    September 10, 2013
    Manufacturer
    SURETEX-THAILAND
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, 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

    CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS LLC THAT DUE TO CONDOM BREAKAGE WHILE USING LIFESTYLES POLYISOPRENE LUBRICATED CONDOM, MEDICAL ATTENTION WAS REQUIRED DUE TO BEING EXPOSED TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453058 LIFESTYLES SKYN LUBRICATED POLYISOPRENE CONDOMS HIS SURETEX-THAILAND 130509021C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other