BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES SKYN

    MDR report key: 4843464 · Received June 11, 2015

    Report

    Report Number
    1019632-2015-00008
    Event Type
    Injury
    Date Received
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    SURETEX, LTD
    Product Code
    MOL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, 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 IMMEDIATELY AFTER USING A LIFESTYLES POLYISOPRENE EXTRA LUBRICATED CONDOM SHE DEVELOPED AN IRRITATION AND TWO (2) DAYS LATER DEVELOPED A YEAST INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381049 LIFESTYLES SKYN EXTRA LUBRICATED POLYISOPRENE CONDOM MOL SURETEX, LTD 1403120522

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other