BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES SKYN

    MDR report key: 3208856 · Received June 14, 2013

    Report

    Report Number
    1019632-2013-00014
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SURETEX-THAILAND
    Product Code
    MOL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS LLC THAT AFTER USING THE LIFESTYLES POLYISOPRENE LUBRICATED CONDOM SHE HAD REPEATEDLY DEVELOPED YEAST INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272374 LIFESTYLES SKYN LUBRICATED POLYISOPRENE CONDOM MOL SURETEX-THAILAND 1205240600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other