BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1269856 · Received December 18, 2008

    Report

    Report Number
    2214133-2008-00009
    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
    KMJ
    PMA / PMN Number
    K040340
    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 THIS COMPLAINT CATEGORY REVEALED NO SIGNIFICANT ADVERSE TRENDS AND NO TREND INVOLVING THIS LOT NUMBER. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THE RETAIN SAMPLE WAS EXAMINED AND PRESENTED A QUALITY APPEARANCE FOR BOTH PACKAGING AND PRODUCT. THE RETAIN SAMPLE WAS TESTED FOR: APPEARANCE-MEETS SPEC. VISCOSITY - MEETS SPEC. ODOR - MEETS SPEC. CONDITION OF CONTAINER - MEETS SPEC. BATCH RECORDS WERE REVIEWED, AND NO DEFECTS WERE NOTED.

    Description of Event or Problem · 1

    APPLIED TO GENITALS AND DEVELOPED BURNING, REDNESS AND BLISTERS FILLED WITH PUS ON GENITALS.

    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 KMJ MCNEIL-PPC, INC. NA 0297C

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other