BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSA-VIEW

    MDR report key: 1961464 · Received December 29, 2010

    Report

    Report Number
    1961464
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    October 30, 2010
    Report Date
    December 29, 2010
    Manufacturer
    VITAL SIGNS, INC
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN A PRONE POSITION FOR A SURGICAL PROCEDURE FOR MORE THAN 4 HOURS THAT RESULTED IN A REDDENED AREA ACROSS THE FOREHEAD.THIS IS A RECENT OCCURRENCE. NO OTHER PROBLEMS NOTED WITH THIS PRODUCT IN THE PAST.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE FAILED TO ADEQUATELY SUPPORT THE HEAD.====================== MANUFACTURER RESPONSE FOR PRONE POSITION PILLOW, DISPOSA-VIEW DISPOSABLE PRONE POSITION HEAD CUSHION======================THERE HAS BEEN NO CHANGE IN THE FOAM DENSITY OR DESIGN OF THE PILLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSA-VIEW PRONE POSITION HEAD CUSHION CCX VITAL SIGNS, INC * 201005

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR