BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLES THYN

    MDR report key: 2985482 · Received February 26, 2013

    Report

    Report Number
    1019632-2013-00008
    Event Type
    Other
    Date Received
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SURETEX LTD.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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

    END USER ADVISED ANSELL HEALTHCARE LLC SHE WAS GOING TO THE DOCTOR AND BE TESTED FOR STD'S

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81314 LIFESTYLES THYN LUBRICATED LATEX CONDOM HIS SURETEX LTD. 1010060716

    Patients

    Seq Age Sex Outcome Treatment
    1 Other