BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 10789270 · Received November 4, 2020

    Report

    Report Number
    2438477-2018-00083
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    March 19, 2018
    Report Date
    November 4, 2020
    Manufacturer
    JAN MAO INDUSTRIES CO., LTD.
    Product Code
    ILS
    UDI-DI
    50822383121098
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A STEEL DROP-ARM COMMODE WITH WHEELS AND PADDED ARMRESTS. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. END-USER WAS SITTING IN THE WHEELED COMMODE IN THE SHOWER. HE WAS SITTING BACK AND THEN LEANED FORWARD TO REACH A GRAB BAR. THE COMMODE SLIPPED AND HE FELL INTO THE WALL. HE RECEIVED A BLACK EYE, BRUISING ON THE BACK OF HIS HEAD, NECK, AND BACK. HE WAS TOO EMBARRASSED TO SEEK MEDICAL ATTENTION. THE DEVICE WAS NOT RETURNED FOR EVALUATION.. THERE ARE NO HISTORICAL COMPLAINTS OF THIS NATURE. PROBABLE ROOT CAUSE IS DUE TO OCCUPANT LEANING FORWARD AND NOT SITTING ALL THE WAY BACK ON THE SEAT. THIS RESULTED IN UNEVEN WEIGHT DISTRIBUTION ON THE UNIT. THIS WILL BE CONSIDERED AN ISOLATED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253851 DRIVE COMMODE ILS JAN MAO INDUSTRIES CO., LTD. 11101W-2 50822383121098

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization