BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 4152998 · Received October 8, 2014

    Report

    Report Number
    2381757-2014-00072
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 12, 2014
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    EYQ
    PMA / PMN Number
    PNONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT SHE FELT THE USE OF PADS LEAD TO HER BEING DIAGNOSED BY HER PHYSICIAN WITH A KIDNEY INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632258 POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ KIMBERLY-CLARK CORPORATION - CONWAY MILL AC416603X0608

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other