BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND YOURS + MINE

    MDR report key: 1381511 · Received May 13, 2009

    Report

    Report Number
    2214133-2009-00007
    Event Type
    Injury
    Date Received
    May 13, 2009
    Date of Event
    March 20, 2009
    Report Date
    May 13, 2009
    Manufacturer
    MCNEIL-PPC, INC
    Product Code
    NUC
    PMA / PMN Number
    K072421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED IN QA. THE COMPONENT LOT NUMBERS FOR THE LOT NUMBER REPORTED 3368D ARE 0508DMH AND 0598DYH. THE RETAIN SAMPLE WAS EXAMINED AND PRESENTED A QUALITY APPEARANCE FOR BOTH PACKAGING AND PRODUCT. THE RETAIN SAMPLE FOR LOT NUMBER 0508DMH WAS TESTED FOR: APPEARANCE, ODOR BENZOIC ACID, AND PH AND ALL MET SPECIFICATION. THE RETAIN SAMPLE FOR LOT NUMBER 0598DYH WAS TESTED FOR: APPEARANCE, ODOR, AND METHYLPARABEN AND ALL MET SPECIFICATION. BATCH RECORDS WERE REVIEWED FOR ALL LOTS AND NO DEFECTS WERE NOTED. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY (PHYSICAL REACTION-SERIOUS) REVEALED NO OTHER COMPLAINTS OF THIS NATURE INVOLVING THIS PRODUCT. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    I BOUGHT THIS PRODUCT WHEN I WAS 8 MONTH PREGNANT. WE USED IT ONE TIME. IT MADE ME REALLY IRRITATED. TWO DAYS LATER, I WENT INTO LABOR 5 WEEKS EARLY, AND THEY SAID IT WAS CAUSED FROM UNKNOWN IRRITATION OR INFECTION. ANYWAY, BECAUSE IT IRRITATED ME SO BAD, THEY THOUGHT THAT MAYBE THAT'S WHAT MADE MY WATER BREAK PREMATURELY, BUT THEY WERE NOT SURE. I JUST HAD A PAP SMEAR THE WEEK BEFORE, AND EVERYTHING WAS FINE. DELIVERY WAS EMERGENCY CESAREAN. BABY BORN 5 WEEKS PREMATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND YOURS + MINE PERSONAL LUBRICANT NUC MCNEIL-PPC, INC NONE 3368D

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other