BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND SENSUAL SILK WARMING

    MDR report key: 1269859 · Received December 18, 2008

    Report

    Report Number
    2214133-2008-00012
    Event Type
    Injury
    Date Received
    December 18, 2008
    Date of Event
    November 14, 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

    NO VALID 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

    CONSUMER REPORTED BURNING SENSATION, RAISED RASH, BLISTERS IN VAGINAL AREA. SYMPTOMS ABATING. CONTACTED HEALTHCARE PROVIDER. TREATMENT OF VALTREX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND SENSUAL SILK WARMING PERSONAL LUBRICANT KMJ MCNEIL-PPC, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other