BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1269857 · Received December 18, 2008

    Report

    Report Number
    2214133-2008-00010
    Event Type
    Injury
    Date Received
    December 18, 2008
    Date of Event
    November 14, 2008
    Report Date
    December 18, 2008
    Manufacturer
    NCNEIL-PPC, INC.
    Product Code
    NUC
    PMA / PMN Number
    K040340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED. A REVIEW OF THE COMPLAINT DATA REVEALED NO SIGNIFICANT ADVERSE TRENDS FOR COMPLAINTS OF THIS NATURE INVOLVING THIS PRODUCT. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    PRODUCT APPLIED TO LEGS AND BUTTOCKS. DEVELOPED A BURN ON THE INSIDE OF LEGS AND THE BUTTOCKS AREA DEVELOPED BIG BLISTERS. WENT TO ER AND WAS TREATED WITH DRESSINGS AND HAD TO SEE SOMEONE FROM WOUND CENTER. TREATMENT WITH SILVADENE. CHANGE BANDAGE 3 X A DAY.

    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 NCNEIL-PPC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other