BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND YOURS + MINE

    MDR report key: 1387668 · Received May 15, 2009

    Report

    Report Number
    2214133-2009-00008
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    April 19, 2009
    Report Date
    May 15, 2009
    Manufacturer
    MCNEIL-PPC, INC.
    Product Code
    NUC
    PMA / PMN Number
    K072421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED TO DATE. THE LOT NUMBER REPORTED BY THE CONSUMER FOR KY YOURS IS A COMPONENT OF THE KY YOURS + MINE KIT LOT NUMBER 1968D ALONG WITH KY MINE LOT NUMBER 0128DMH. BOTH RETAIN SAMPLES WERE EXAMINED AND PRESENTED A QUALITY APPEARANCE FOR BOTH PACKAGING AND PRODUCT. THE RETAIN SAMPLE FOR LOT NUMBER 0128DMH WAS TESTED FOR: APPEARANCE - MEETS SPEC. ODOR - MEETS SPEC. BENZOIC ACID - MEETS SPEC. PH - MEETS SPEC. THE RETAIN SAMPLE FOR LOT NUMBER 0158DYH WAS TESTED FOR: APPEARANCE - MEETS SPEC. ODOR - MEETS SPEC. METHYLPARABEN - MEETS SPEC. BATCH RECORDS WERE REVIEWED FOR ALL LOTS AND NO DEFECTS WERE NOTED. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO OTHER COMPLAINTS OF THIS NATURE INVOLVING THIS LOT NUMBER. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    CONSUMER USED HIS (YOURS) PRODUCT AND HAD ORAL SEX AND DEVELOPED A SORE THROAT. THROAT SWELLING ALMOST SHUT. HAD BREATHING PROBLEMS BECAUSE ALMOST HAD NO AIRWAY. CONSUMER STATES DOCTOR TOLD HER IF SHE WAITED ANY LONGER, SHE WOULD HAVE NEEDED A TRACH. HE DIAGNOSED HER WITH SEVERE ALLERGIC REACTION. SHE WENT TO THE ER AND WAS TREATED WITH SEVERAL INJECTIONS, EPINEPHRINE AND BENADRYL AND UNKNOWN OTHERS. SYMPTOMS HAVE ABATED. SHE WAS ADVISED TO NOW CARRY AN EPI-PEN AND TAKE BENADRYL BID. CONSUMER USED PRODUCT FOR FIRST TIME IN 2009, BUT NOT FOR ORAL SEX THAT TIME. SHE USED IT FOR ORAL SEX TWO DAYS LATER, AND DEVELOPED SORE THROAT SHORTLY AFTERWARDS AND SEVERAL HOURS LATER THE NEXT DAY, DEVELOPED THE MORE SERIOUS PROBLEMS AND WENT TO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND YOURS + MINE PERSONAL LUBRICANT NUC MCNEIL-PPC, INC. NONE 0158DYH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other