BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLE ULTRA SENSITIVE

    MDR report key: 3212995 · Received April 12, 2013

    Report

    Report Number
    1019632-2013-00010
    Event Type
    Other
    Date Received
    April 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SURETEX LTD.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    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

    END USER ADVISED ANSELL HEALTHCARE LLC THAT AFTER USING THE LS ULTRA SENSITIVE CONDOM SHE WOKE UP WITH A HORRIBLE BURNING IN THE VAGINAL AREA. SHE WAS ADVISED BY NURSE OVER THE PHONE TO USE A CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159888 LIFESTYLE ULTRA SENSITIVE LUBRICATED LATEX CONDOM HIS SURETEX LTD. 1007020922

    Patients

    Seq Age Sex Outcome Treatment
    1 Other