BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLERS SKYN

    MDR report key: 3855869 · Received May 13, 2014

    Report

    Report Number
    1019632-2014-00007
    Event Type
    Injury
    Date Received
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SURETEX LTD
    Product Code
    MOL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    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 POLYISOPRENE LUBRICATED CONDOM SHE HAS SUFFERED SEVERE VAGINAL BURNING FOR OVER A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286636 LIFESTYLERS SKYN LUBRICATED POLYISOPRENE CONDOM MOL SURETEX LTD 1210123316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other