BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN SHOULDER CHAIR

    MDR report key: 3345294 · Received August 9, 2013

    Report

    Report Number
    1221538-2013-00012
    Event Type
    Malfunction
    Date Received
    August 9, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SHOULDER CHAIR, A DEVICE WHICH ATTACHES TO THE OPERATING ROOM TABLE FOR PT SUPPORT DURING SHOULDER SURGERY, MOVED OUT OF POSITION. THERE WAS A PT PRESENT, BUT NOT INJURED. THERE WAS AN INJURY TO STAFF (CRNA STUCK IN CLAVICLE), BUT TREATMENT WAS REFUSED. THE DEVICE WAS NOT AVAILABLE FOR EVAL AT THE TIME THIS REPORT WAS FILED. IF THE DEVICE BECOMES AVAILABLE, AN INVESTIGATION WILL BE PERFORMED AND ANY RELEVANT RESULTS WILL BE REPORTED IN A F/U MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380739 ALLEN SHOULDER CHAIR SHOULDER CHAIR FWZ ALLEN MEDICAL SYSTEMS, INC. O-SC-A4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other