BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA ORTHO MED NOVA BEDSIDE COMMODE

    MDR report key: 16333964 · Received February 9, 2023

    Report

    Report Number
    16333964
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    February 2, 2023
    Report Date
    February 2, 2023
    Manufacturer
    NOVA ORTHO-MED, INC.
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT BEING ASSISTED BY PCA UTILIZING GAIT BELT TO TRANSFER TO BEDSIDE COMMODE. LEG OF COMMODE BENT CAUSING PATIENT FELL TO THE FLOOR. PATIENT DID NOT HIT HIS HEAD. PATIENT SUSTAINED A SMALL SKIN TEAR UNDER LEFT EAR, AND SCRATCH UNDER RIGHT ARM WHERE BLOOD PRESSURE CUFF WAS STILL ATTACHED. COMMODE TAKEN OUT OF SERVICE. PATIENT WEIGHT APPROX 230 POUNDS. COMMODE CERTIFIED FOR UP TO 250 POUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462088 NOVA ORTHO MED NOVA BEDSIDE COMMODE ADAPTOR, HYGIENE ILS NOVA ORTHO-MED, INC. BL8450

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA Male Other