BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7" GENTLETOUCH PILLOW

    MDR report key: 1290563 · Received January 15, 2009

    Report

    Report Number
    2921578-2009-00001
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    December 11, 2007
    Report Date
    January 15, 2009
    Manufacturer
    MIZUHO OSI
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN EXTREMELY ODD EVENT, WE HAVE CONTACTED THE USER FACILITY, BUT HAVE NOT HAD A RETURN RESPONSE.

    Description of Event or Problem · 1

    ANESTHETIZED PATIENT UNDERGOING CERVICAL LYMPH NODE BIOPSY IN PRONE POSITION WITH FACE IN FOAM HEADREST. A FLASH FIRE OCCURRED. ACCORDING TO THE HOSPITAL'S MEDWATCH REPORT, THIS EVENT DID NOT INVOLVE AN ELECTROPHYSIOLOGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7" GENTLETOUCH PILLOW PILLOW FWZ MIZUHO OSI 1937

    Patients

    Seq Age Sex Outcome Treatment
    1 Other