BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 8716135 · Received June 20, 2019

    Report

    Report Number
    9615625-2019-00002
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    March 5, 2019
    Report Date
    June 20, 2019
    Manufacturer
    KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO. ,LTD
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING FACILITY IS CONDUCTING A REVIEW OF THE DHR (DEVICE HISTORY RECORD) AND SUPPORTING QUALITY RECORDS.

    Description of Event or Problem · 1

    CONSUMER REPORTED HE EXPERIENCED A BURNING, PAINFUL IRRITATION IN THE GROIN AREA AND WAS USING CREAM AND TOILET PAPER AS A BARRIER WHILE WEARING THE PADS. HE HAD BLOOD IN HIS URINE AFTER WEARING A PAD FOR THREE DAYS. HE WAS DIAGNOSED WITH A URINARY TRACT INFECTION AND HOSPITALIZED FOR ONE DAY. WHILE IN THE HOSPITAL HE WAS ADMINISTERED IV ANTIBIOTICS AND GIVEN 850MG PILLS THAT HE TOOK FOR TWO WEEKS. HE NO LONGER HAD BLOOD IN HIS URINE AND HIS SYMPTOMS HAD IMPROVED. HE STOPPED USING THE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511492 DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO. ,LTD INCONTINENCE SHIELDS FOR MEN, LIGHT ABSORBENCY BJ823505X0246

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR