BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND TOUCH MASSAGE 2-IN-1 WARMING

    MDR report key: 1387667 · Received May 15, 2009

    Report

    Report Number
    2214133-2009-00006
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    July 1, 2007
    Report Date
    May 15, 2009
    Manufacturer
    MCNEIL-PPC, INC.
    Product Code
    NUC
    PMA / PMN Number
    K040340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER PROVIDED. A REVIEW OF THE DATA ASSOCIATED WITH THESE COMPLAINT CATEGORIES WAS REVISED FOR ALL K-Y PRODUCTS THAT WERE AVAILABLE DURING THE PERIOD OF 2007. THERE WERE NO SIGNIFICANT ADVERSE TRENDS FOR COMPLAINTS OF THIS NATURE FOR ANY PRODUCT AVAILABLE AT THAT TIME. IF INFORMATION ON THE LOT NUMBER IS RECEIVED, BATCH RECORD REVIEW AND RETAIN SAMPLE TESTING WILL BE REQUESTED OF THE MANUFACTURER. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE DETERMINED WHETHER THE REPORT IS FOR A MEDICAL DEVICE OR A COSMETIC PRODUCT. THEREFORE, A MANDATORY MDR AND A VOLUNTARY 3500 ARE FILED WITH THE SAME DESCRIPTION. THE PRODUCT WAS USED FOR 5 MONTHS, IN 2007 WHEN THE CONSUMER BEGAN TO EXPERIENCE STICKINESS, RASH SYMPTOMS AND SORENESS. SHE ALSO BEGAN TO EXPERIENCE URINARY TRACT INFECTIONS FOR THE FIRST TIME IN HER LIFE. IN EARLY 2008, HER SKIN WAS RAW AND DEVELOPED ANOTHER INFECTION. SHE HAS CONTINUED TO HAVE DERMATITIS, YEAST INFECTIONS, REDNESS, RAWNESS, AND BURNING, AND HAS A DECREASE IN SEXUAL ACTIVITY AS A RESULT. IN ADDITION, SHE HAS BEEN UNABLE TO ENGAGE IN HER OCCUPATION AS A VOCATIONAL INSTRUCTOR DUE TO THE PAIN AND HAS REQUESTED A LEAVE OF ABSENCE. CONSUMER HAS SOUGHT MEDICAL TREATMENT AND LEARNED THAT SHE HAD VULVAR DERMATITIS AND HER GYNECOLOGIST ATTRIBUTED IT TO THE USE OF A LOTION OF CREAM. THE K-Y PRODUCT WAS THE ONLY PRODUCT CONSUMER HAD EVER USED IN THAT AREA OF THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND TOUCH MASSAGE 2-IN-1 WARMING BODY MASSAGE + PERSONAL LUBRICANT NUC MCNEIL-PPC, INC. NONE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other