BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND YOUR + MINE

    MDR report key: 1212652 · Received October 24, 2008

    Report

    Report Number
    2214133-2008-00007
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 29, 2008
    Manufacturer
    CONSUMER HEALTHCARE PRODUCTS DIVISION OF MCNEIL-PPC, INC.
    Product Code
    NUC
    PMA / PMN Number
    K072421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS REPORTED BY THE CONSUMER. A RETURNED SAMPLE HAS NOT BEEN RECEIVED. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO SIGNIFICANT ADVERSE TRENDS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    CONS STATED HIS WIFE APPLIED PROD TO VAGINAL AREA AND DEVELOPED VAGINAL BURNING. SHE DEVELOPED A UTI 4 DAYS LATER AND HUSBAND STATES, IT WAS SPREADING AND NOT RESPONDING TO ANTIBIOTICS. SHE HAD TO BE HOSPITALIZED FOR THREE DAYS IN 2008 BECAUSE HER OTHER MEDS HAD TO BE DC'D, DUE TO POSSIBLE COMPLICATIONS. SHE IS CURRENTLY ON MACROBID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND YOUR + MINE PERSONAL LUBRICANT NUC CONSUMER HEALTHCARE PRODUCTS DIVISION OF MCNEIL-PPC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization