BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 5567357 · Received April 11, 2016

    Report

    Report Number
    2381757-2016-00013
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 28, 2016
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    EYQ
    PMA / PMN Number
    PNONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MANUFACTURING, QUALITY AUDIT, PRODUCTION, RAW MATERIAL AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. COMPLAINT SAMPLE WAS NOT RETURNED THEREFORE A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    THIS IS A NON-US EVENT. THE CONSUMER STATED THAT SHE WAS DIAGNOSED WITH KIDNEY INFECTION, AND THAT HER DOCTOR STATED THE INFECTION COULD HAVE BEEN FROM THE PADS SHE WAS USING. SHE WAS PRESCRIBED MEDICATION AND BEGAN TAKING IT ON (B)(6). THE CONSUMER REPORTED ON (B)(6) THAT SHE WAS SYMPTOM-FREE AND HER INFECTION APPEARED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223313 POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ KIMBERLY-CLARK CORPORATION - CONWAY MILL POISE LINERS LONG AC527103X0537

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention