BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTHLINE SHOWER COMMODE CHAIR

    MDR report key: 2894646 · Received April 10, 2008

    Report

    Report Number
    2894646
    Event Type
    Malfunction
    Date Received
    April 10, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 8, 2008
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    REAR LEFT BOTTOM PVC PIPE BROKEN. REAR MIDDLE JOINT BROKEN. RESIDENT WAS IN CHAIR WHEN IT BROKE. BOTH THE RESIDENT AND CNA FELL TO THE FLOOR. THE RESIDENT WAS NOT HURT. THE CNA EXPERIENCED MINOR KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTHLINE SHOWER COMMODE CHAIR SHOWER CHAIR INM SC6014X

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR