BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON UNIVERSITY SUSPENSION

    MDR report key: 590619 · Received April 11, 2005

    Report

    Report Number
    MW1035143
    Event Type
    Malfunction
    Date Received
    April 11, 2005
    Date of Event
    March 25, 2005
    Report Date
    March 30, 2005
    Manufacturer
    PILLING USA
    Product Code
    EPW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUSPENSION BROKE AND PT'S HEAD DROPPED TO O.R. TABLE, WHICH WAS PADDED. PROCEDURE (MICROLARYNGOSCOPY) HAD BEEN COMPLETED, NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON UNIVERSITY SUSPENSION HEAD SUSPENSION EPW PILLING USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR