BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUREX MAXIMUM

    MDR report key: 449284 · Received March 21, 2003

    Report

    Report Number
    1065445-2003-00004
    Event Type
    Other
    Date Received
    March 21, 2003
    Report Date
    March 20, 2003
    Manufacturer
    TTK-LIG LTD
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CONSUMER USED A DUREX CONDOM AND REPORTED DISCOMFORT AND BLEEDING AFTER USE. THEY COMPLAINED OF A LACK OF LUBRICATION. NO ADD'L INFO GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUREX MAXIMUM CONDOM HIS TTK-LIG LTD NA LOTVR2035

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other INFO UNKNOWN