BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE STYLES PREMIUM LUBRICATED LATEX CONDOM KING XL SIZE

    MDR report key: 2163639 · Received July 11, 2011

    Report

    Report Number
    MW5021335
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 11, 2011
    Product Code
    HIS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CONDOM BREAKAGE DURING INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE STYLES PREMIUM LUBRICATED LATEX CONDOM KING XL SIZE LIFE STYLES PREMIUM LUBRICATED LATEX CONDOM KING XL SIZE HIS 0710122416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other