BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVACARE I-CLASS ALL-IN-ONE COMMODE - SINGLE PACK

    MDR report key: 20179759 · Received September 10, 2024

    Report

    Report Number
    20179759
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 13, 2024
    Manufacturer
    INVACARE CORPORATION
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ELDERLY FEMALE WITH HISTORY OF PRIOR STROKE. ADMITTED FOR GENERALIZED WEAKNESS AND CONFUSION. PROCEDURE: ASSISTED ONTO BEDSIDE COMMODE- WHEN SEATED, LID FELL OFF CONTAINER, SEAT AND METAL SUPPORTS FELL TO GROUND. PATIENT BOTTOM LOWERED THROUGH HOLE FROM MISSING EQUIPMENT BUT DID NOT TOUCH GROUND. ASSISTED OUT OF COMMODE WITHOUT KNOWN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223482 INVACARE I-CLASS ALL-IN-ONE COMMODE - SINGLE PACK ADAPTOR, HYGIENE ILS INVACARE CORPORATION 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Female