BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND YOUR + MINE

    MDR report key: 1269858 · Received December 18, 2008

    Report

    Report Number
    2214133-2008-00011
    Event Type
    Injury
    Date Received
    December 18, 2008
    Date of Event
    November 10, 2008
    Report Date
    December 18, 2008
    Manufacturer
    MCNEIL-PPC, INC.
    Product Code
    NUC
    PMA / PMN Number
    K072421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DATA ASSOCIATED WITH THESE COMPLAINT CATEGORIES REVEALED NO SIGNIFICANT ADVERSE TRENDS AND NO OTHER COMPLAINTS OF THIS NATURE INVOLVING THIS LOT NUMBER. A REVIEW OF ALL MEDICAL COMPLAINTS SHOWED THAT THERE WERE NO OTHER COMPLAINTS ALLEGING THESE SYMPTOMS FOR THIS PRODUCT. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    CONSUMER REPORTS PRODUCT MAY HAVE CAUSED HER BOYFRIEND TO BE LIGHT HEADED AND HEART POUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND YOUR + MINE PERSONAL LUBRICANT NUC MCNEIL-PPC, INC. NA 1728D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other