BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLES SKYN

    MDR report key: 2773658 · Received October 1, 2012

    Report

    Report Number
    1019632-2012-00010
    Event Type
    Other
    Date Received
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SURETEX-THAILAND
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (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 AFTER USING THE LIFESTYLES POLYISOPRENE LUBRICATED CONDOM HE AND HIS GIRLFRIEND EXPERIENCED IRRITATION. THE GIRLFRIEND'S AUNT IS AN RN AND ADVISED HER TO USE THE (B)(4) VERSION OF BENADRYL AND THE (B)(4) BRAND OF BENADRYL CREAM. ALSO, THE GIRLFRIEND HAD PREVIOUSLY BEEN EXPOSED TO LATEX SO THAT IS HOW SHE KNEW SHE WAS HAVING AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLES SKYN LUBRICATED POLYISOPRENE CONDOMS HIS SURETEX-THAILAND 1107063316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other