BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRONE POSITIONER

    MDR report key: 609992 · Received June 30, 2004

    Report

    Report Number
    1643116-2004-00001
    Event Type
    Other
    Date Received
    June 30, 2004
    Date of Event
    May 27, 2000
    Report Date
    June 24, 2004
    Manufacturer
    VOSS MEDICAL PRODUCTS
    Product Code
    KIL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN A PRONE POSITION FOR AN EXTENDED PERIOD OF TIME DURING A SURGICAL PROCEDURE. PT DEVELOPED AN ABRASION/CONTUSION ON THE CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRONE POSITIONER HEAD SUPPORT FOR PRONE SURGICAL PROCEDURES KIL VOSS MEDICAL PRODUCTS P-39-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other