BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

    MDR report key: 4096393 · Received September 17, 2014

    Report

    Report Number
    2184163-2014-00003
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 15, 2014
    Manufacturer
    NEENAH COLD SPRING FACILITY
    Product Code
    EYQ
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED BY THE CONSUMER. 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 WAS HOSPITALIZED ON 2 OCCASIONS FOR UTI KIDNEY INFECTIONS AFTER INCONTINENCE GARMENTS USAGE. CONSUMER RECEIVED IV ZOSYN IN THE HOSPITAL AND PRESCRIBED ORAL ANTIBIOTIC FOR 5 DAYS UPON DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574559 DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ GARMENT, PROTECTIVE, FOR INCONTINENCE EYQ NEENAH COLD SPRING FACILITY DEPEND FOR MEN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization