BEUDAMED
    FDA Adverse Event Other Summary report: N

    POISE PADS

    MDR report key: 2680475 · Received July 24, 2012

    Report

    Report Number
    MW5026354
    Event Type
    Other
    Date Received
    July 24, 2012
    Date of Event
    April 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    EYQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM LOOKING FOR SOMEONE TO FIND ANSWERS, HELP END THE PAIN I HAVE, AND GET THIS PRODUCT OFF THE MARKET. IN (B)(6), FOR LIGHT BLADDER LEAKAGE, I USED POISE PADS, AS I HAVE FOR OVER TEN YEARS. NEW ONES HAVE PURPLE PRINT ALL OVER THE PAD. THEY CAUSED A BURNING FEELING EVERYWHERE THE PAD TOUCHED. I HAVE BEEN TO TWO DOCTORS, USED FOUR PRESCRIPTION CREAMS, AND NOTHING HAS HELPED. I HAVE HAD THIS PAIN FOR OVER (B)(6) MONTHS. I CALLED KIMBERLY CLARK, THE MFR, TWO TIMES AND GOT NO HELP THERE. TOLD ME IF I'M NOT STILL WEARING THE PADS, THE BURNING SHOULD STOP AND DENIED ANY CHANGES TO THE PRODUCT. I KNOW THERE ARE OTHER WOMEN WITH THIS PROBLEM BECAUSE I CHECKED ON LINE AND FOUND COMPLAINTS OF THE SAME THING. PLEASE CAN YOU CHECK THIS PRODUCT, HELP GET ANSWERS AND RELIEF FOR THE PAIN, AND GET THIS PRODUCT OFF THE MARKET?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POISE PADS INCONTINENCE PAD EYQ KIMBERLY-CLARK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other