BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE COMMODES

    MDR report key: 468502 · Received June 26, 2003

    Report

    Report Number
    1525712-2003-00075
    Event Type
    Injury
    Date Received
    June 26, 2003
    Date of Event
    March 28, 2003
    Report Date
    June 25, 2003
    Manufacturer
    INVACARE CORPORATION
    Product Code
    KNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER STATED THEY WERE SITTING IN THE REHAB SHOWER COMODE CHAIR USING AN ELECTRICAL STIMULATOR TO ASSIST IN USING THE RESTROOM, WHEN THE BACK UPHOLSTERY ALLEGEDLY SLIDE DOWN. PT ALLEGEDLY HIT THEIR HEAD AND LOST CONSCIOUSNESS. THE DIGITAL STIMULATOR WAS ALLEGEDLY STILL INSIDE PT'S RECTUM AND WHEN THEIR LEGS CAME OFF THE CHAIR, IT CAUSED TEARING OF THEIR INSIDES REQUIRING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE COMMODES 890.3920 KNN INVACARE CORPORATION 6695 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization