BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND YOURS+MINE

    MDR report key: 1309875 · Received February 9, 2009

    Report

    Report Number
    2214133-2009-00002
    Event Type
    Injury
    Date Received
    February 9, 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

    KY YOURS AND MINE CONTAINS TWO PERSONAL LUBRICANTS - ONE YOURS (FOR HIM) AND ONE MINE (FOR HER). THE LOT NUMBER PROVIDED BY THE CONSUMER (23880) IS INVALID. THE CLOSEST VALID FINISHED GOODS LOT NUMBER FOR THIS PRODUCT IS 2388D, SO AN INVESTIGATION WAS PERFORMED FOR LOT 2388D. THE COMPONENT LOT NUMBERS FOR 2388D ARE 0308DMH (MINE), 0358DYH (YOURS) AND 0368DYH (YOURS). THE RETAIN SAMPLE FOR LOT 0308DMH WAS TESTED FOR APPEARANCE, ODOR, BENZOIC ACID, AND PH AND MET SPECIFICATION. THE RETAIN SAMPLE FOR LOTS 0358DYH AND 0368DYH WERE BOTH TESTED FOR APPEARANCE, ODOR, AND METHYLPARABEN AND MET SPECIFICATION. THE RETURNED COMPLAINT SAMPLE WAS SUBSEQUENTLY RECEIVED ON 01/21/09. THE FINISHED GOODS LOT NUMBER WAS CONFIRMED TO BE 2388D. THE COMPONENT LOT NUMBERS FOR FINISHED GOODS LOT 2388D WERE 0308DMH AND 0368DYH. THE RETURNED SAMPLE 0308DMH WAS TESTED FOR APPEARANCE, ODOR, BENZOIC ACID, AND PH AND MET SPECIFICATION. THE RETURNED SAMPLE 0368DYH WAS TESTED FOR APPEARANCE, ODOR, AND METHYLPARABEN AND MET SPECIFICATION. BATCH RECORDS WERE REVIEWED AND NO DEFECTS WERE NOTED. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO ADVERSE TRENDS, AND NO OTHER COMPLAINTS OF THIS NATURE INVOLVING THIS LOT NUMBER. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    CONSUMER STATES HIM AND HIS WIFE USED PRODUCT ON FRIDAY NIGHT BETWEEN 6:30 AND 7:00 PM. WENT TO DINNER. AT 1:30 AM CONSUMER AWOKE AND WAS HAVING A HARD TIME BREATHING. CONSUMER STATES HIS UVULA HAD SWOLLEN AND WAS BLOCKING HIS AIRWAY. CONSUMER WAS TAKEN TO ER VIA AMBULANCE AND AT ER WAS GIVEN IV BENADRYL AND EPINEPHRINE. DOCTOR STATED CUSTOMER HAD AN ALLERGIC REACTION TO SOMETHING. CONSUMER STATES HE FEELS IT WAS FROM K-Y PRODUCT. CONSUMER STATES PRODUCT MAY HAVE GOTTEN TO HIS MOUTH FROM HAND TO MOUTH CONTAMINATION. CONSUMER STATES SYMPTOMS HAVE ABATED. CCC CALLED CONSUMER BACK FOR AN UPDATE ON HIS STATUS. MR. ... WAS NOT AVAILABLE TO SPEAK WITH. HOWEVER, SPOKE WITH HIS WIFE ON THE PHONE. SHE ADVISED THAT HE IS BACK TO WORK AND SYMPTOMS HAVE ABATED. IN REVIEWING THE EVENT WITH MRS. ... SHE CONFIRMED THAT SHE CALLED EMERGENCY MEDICAL SERVICES TO HER HOME AFTER HER HUSBAND HAD AN "ALLERGIC REACTION" TO POSSIBLY K-Y YOURS+MINE COUPLE LUBRICANT. IN THE ER, CONSUMER WAS TREATED INTRAVENOUSLY WITH A STEROID, BENADRYL, AND EPINEPHRINE. HIS UVULA WAS SWOLLEN TO "THE SIZE OF A WALNUT." MRS. ... STATES HER HUSBAND'S COLOR, ALTHOUGH PALE, NEVER BECAME CYANOYIC. HE WAS LATER RELEASED WITH PRESCRIPTIONS FOR AN ANTIHISTAMINE AND A STEROID. CUSTOMER FOLLOW UP WITH HIS FAMILY HCP WHO PRESCRIBED EPI PEN PRN. MR. ... STATED SHE AND HER HUSBAND ARE NOT SURE IF IT WAS THE K-Y PRODUCT THAT LET TO THIS EVENT, HOWEVER, THEY DO NOT FEEL IT WAS ANYTHING THEY CONSUMED EARLIER IN THE EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND YOURS+MINE PERSONAL LUBRICANT NUC MCNEIL-PPC, INC. NONE 2388D

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other LIPITOR