BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLES ULTRA SENSITIVE

    MDR report key: 2898571 · Received January 3, 2013

    Report

    Report Number
    1019632-2013-00001
    Event Type
    Other
    Date Received
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    SURETEX-THAILAND
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 LIFESTYLES ULTRA SENSITIVE CONDOM HIS WIFE SUFFERED AN ALLERGIC REACTION THAT REQUIRED MEDICAL ATTENTION FROM THE HOSPITAL. THE WIFE WAS GIVEN INTERVENES STEROIDS AND ANTIHISTAMINES TO TREAT THE SEVERE HIVES AND RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077 LIFESTYLES ULTRA SENSITIVE PREMIUM LUBRICATED LATEX CONDOMS HIS SURETEX-THAILAND 1203030416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other