BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 8851146 · Received August 1, 2019

    Report

    Report Number
    3003701733-2019-00400
    Event Type
    Injury
    Date Received
    August 1, 2019
    Date of Event
    January 1, 1999
    Report Date
    November 19, 2019
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW UP TO REPORT NEW INFORMATION WAS RECEIVED FROM THE CONSUMER. CONSUMER REPORTED SHE HAD NOT BEEN HOSPITALIZED DUE TO HER YEAST INFECTIONS. REPORT TYPE: FOLLOW-UP 1.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP TO REPORT NEW INFORMATION WAS RECEIVED FROM THE CONSUMER. CONSUMER REPORTED SHE HAD NOT BEEN HOSPITALIZED DUE TO HER YEAST INFECTIONS.

    Additional Manufacturer Narrative · 1

    A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED.

    Description of Event or Problem · 1

    CONSUMER REPORTED SHE HAS BEEN EXPERIENCING YEAST INFECTIONS FOR THE LAST 20 YEARS WHILE USING THE PRODUCT. THE YEAST INFECTION TRAVELED TO THE INSIDE OF HER STOMACH AND SHE WAS HOSPITALIZED. SHE RECENTLY SOUGHT MEDICAL ATTENTION FOR A RED ITCHY RASH IN VAGINAL AREA. MEDICATION WAS PRESCRIBED FOR YEAST INFECTION. UPON COMPLETING THE MEDICATION HER SYMPTOMS IMPROVED BUT DID NOT RESOLVE. SHE IS CURRENTLY TAKING PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645128 POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ KIMBERLY-CLARK CORPORATION MODERATE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O