BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES LUBRICATED

    MDR report key: 3698322 · Received February 28, 2014

    Report

    Report Number
    1019632-2014-00005
    Event Type
    Injury
    Date Received
    February 28, 2014
    Report Date
    February 28, 2014
    Manufacturer
    SURETEX LTD
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    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

    THE CUSTOMER ADVISED ANSELL HEALTHCARE PRODUCTS, LLC THAT THE LIFESTYLES LUBRICATED CONDOM HE WAS USING BROKE LEADING HIM TO CONTRACT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125382 LIFESTYLES LUBRICATED LUBRICATED LATEX CONDOM HIS SURETEX LTD 121210031C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other