BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND YOUR & MINE

    MDR report key: 1369287 · Received April 24, 2009

    Report

    Report Number
    2214133-2009-00005
    Event Type
    Injury
    Date Received
    April 24, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 24, 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. THE COMPONENT LOT NUMBERS FOR THE LOT NUMBER REPORTED 3378D ARE 0508DYH. THE RETAINED SAMPLE WAS EXAMINED AND PRESENTED A QUALITY APPEARANCE FOR BOTH PACKAGING AND PRODUCT. THE RETAINED SAMPLE FOR LOT NUMBER 0508DMH WAS TESTED FOR: APPEARANCE - MEETS SPEC. ODOR - MEETS SPEC. BENZOIC ACID - MEETS SPEC. PH- MEETS SPEC. THE RETAINED SAMPLE FOR LOT NUMBER 0598DYH 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 THESE COMPLAINT CATEGORIES REVEALED NO ADVERSE TRENDS AND NO OTHER COMPLAINTS OF THIS NATURE INVOLVING LOT 3378D OR ANY OF ITS COMPONENT LOT NUMBERS. A COMPLAINT TREND WAS PREVIOUSLY IDENTIFIED FOR COMPLAINTS ALLEGING NUMBNESS AND CAPA WAS OPENED TO INVESTIGATE COMPLAINTS OF THIS NATURE. THE CAPA INVESTIGATION CONCLUDED THAT NUMBNESS CAN BE PHYSIOLOGICALLY EXPECTED TO OCCUR IN A SMALL NUMBER OF INDIVIDUALS DUE TO THE PHYSICIAN AND CHEMICAL PROPERTIES OF THE LUBRICATING PRODUCT. COMPLAINT TRENDS WILL CONTINUE TO MONITORED.

    Description of Event or Problem · 1

    IN 2009 - CONSUMER CALLING TO REPORT INTERNAL VAGINAL BURN FROM USE OF PRODUCT, ALSO SMALL AMOUNT OF VAGINAL BLEEDING, URINARY INCONTINENCE AND NUMBNESS TO ENTIRE GENITAL AREA. DID ADVISE CONSUMER TO DISCONTINUE USE OF PRODUCT AND TO CONTACT HER HCP. CONS SAYS SHE SAW HER DOCTOR TODAY AND CONFIRMED INTERNAL CHEMICAL BURN FROM THE MENTHOL IN THIS PRODUCT. CONSUMER SAYS SHE ALSO HAS SMALL AMOUNT OF VAGINAL BLEEDING REQUIRING SANITARY PROTECTION. CONSUMER IS IN MENOPAUSE. CONSUMER SAYS SYMPTOMS NOT ABATING. CONSUMER IS BEING TREATED WITH CLOBETASOL OINTMENT AND VAGIFEM VAGINAL SUPPOSITORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND YOUR & MINE PERSONAL LUBRICANT NUC MCNEIL-PPC, INC NONE 3378D

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other