BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES SKYN

    MDR report key: 4495545 · Received January 13, 2015

    Report

    Report Number
    1019632-2015-00002
    Event Type
    Injury
    Date Received
    January 13, 2015
    Report Date
    January 13, 2015
    Manufacturer
    SURETEX LTD
    Product Code
    MOL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTNG THIS REPORT ON BEHALF OF (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES POLYISOPRENE LUBRICATED CONDOM HE SUFFERED FROM BURNING FOR DAYS THAT REQUIRED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29089 LIFESTYLES SKYN LUBRICATED POLYISOPRENE CONDOM MOL SURETEX LTD 1311120622

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other