BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 764429 · Received September 22, 2006

    Report

    Report Number
    2921578-2006-00004
    Event Type
    Death
    Date Received
    September 22, 2006
    Date of Event
    August 19, 2003
    Report Date
    September 18, 2006
    Manufacturer
    *
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER DISCUSSION WITH ALLEGIANCE HEALTHCARE, IT WAS DETERMINED THAT THE ULTRA SHOULDER POSITIONER DID NOT CAUSE OR CONTRIBUTE TO THE DEATH/ADVERSE EVENT. BECAUSE OF THEIR BELIEF THAT THE DEVICE DID NOT CAUSE THE ADVERSE EVENT, THE HOSP DID NOT CONTACT ORTHOPEDIC SYSTEMS, INC. THE INITIAL CONTACT WAS FROM THE SURGEON.

    Description of Event or Problem · 1

    IT WAS FOUND THAT DURING SHOULDER SURGERY, THE PT NEVER WOKE FROM SURGERY. PATHOLOGY REPORTS DEATH CAUSED BY GLOBAL ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK * JEA * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death ULTRA SHOULDER POSITIONER