BEUDAMED
    FDA Adverse Event Other Summary report: N

    POISE PADS

    MDR report key: 493752 · Received October 23, 2003

    Report

    Report Number
    MW1029981
    Event Type
    Other
    Date Received
    October 23, 2003
    Date of Event
    August 1, 2003
    Report Date
    October 23, 2003
    Manufacturer
    KIMBERLY-CLARK CORP
    Product Code
    EYQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STARTED USING POISE BLADDER CONTROL PADS IN JULY OF 2003. DEVELOPED BURNING URINATION, SPASMS IN THEIR BLADDER, INCREASED URINARY FREQUENCY AND PAIN. THEY WENT TO THE DR AND NO BLADDER INFECTION WAS FOUND. REPORTER THEN RESEACHED THEIR SYMPTOMS AND THEY SOUNDED LIKE INTERSTITIAL CYSTITIS. A VERY PAINFUL AND DEBILITATING BLADDER CONDITION OF UNK ORIGIN. REPORTER DIDN'T CONNECT THE USE OF THE POSIE PADS AND THEIR BLADDER PAIN UNTIL A MONTH AGO. REPORTER NOTICED THEY HAD A FUNNY SMELL, SORT OF A CHEMICAL SMELL. REPORTER E-MAILED THE CO AND ASKED IF THEY USED PERFUMES OR DYES OR ANYTHING FOR ODOR CONTROL. THEY E-MAILED BACK AND SAID NO. IF YOU LOOK ON THE LABEL IT SAYS IT HELPS PREVENT ODORS. THESE PADS HAVE A CHEMICAL SMELL. THERE ARE MILLIONS OF PEOPLE IN THE WORLD (MOSTLY WOMEN) WHO ARE SUFFERING WITH INTERSTITAL CYSTITIS. MEDICAL PROFESSIONALS ARE AT A LOSS AS TO WHAT IS CAUSING IT. RPTR ASKS WHAT IF AT LEAST SOME OF THESE CASES ARE CAUSED BY A TOXIN BEING USED IN THESE PADS. RPTR DOESN'T WANT TO GET ANYONE IN TROUBLE BUT THEY THINK THIS PRODUCT AND ANY OTHER PRODUCT LIKE THIS SHOULD BE CHECKED OUT. REPORTER'S SYMPTOMS HAVE IMPROVED ALOT SINCE THEY STOPPED USING THE PADS BUT THEY STILL ARE HAVING SOME PAIN. RPTR HAS NEVER HAD SYMPTOMS LIKE THIS BEFORE IN THEIR LIFE. IT WAS HORRIBLE. REPORTER SAVED ONE OF THE PADS AND HAS OPENED IT UP AND SMELLED IT AND COMPARED IT WITH UNSCENTED SANITARY NAPKINS AND THEY CAN SMELL THE CHEMICAL SMELL ON THE POISE PAD AND NO SMELL ON THE UNSCENTED SANITARY NAPKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POISE PADS ULTRA EYQ KIMBERLY-CLARK CORP * NS3164P1A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other