BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA SHOULDER POSITIOINER

    MDR report key: 1644569 · Received March 26, 2010

    Report

    Report Number
    2921578-2010-00003
    Event Type
    Other
    Date Received
    March 26, 2010
    Report Date
    March 22, 2010
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL CONTINUE TO MONITOR THIS FOR TRENDING (B)(4).

    Description of Event or Problem · 1

    PT HAD AN ALLERGIC REACTION DURING SURGERY WHILE USING THE ULTRA SHOULDER POSITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA SHOULDER POSITIOINER OPERATING ROOM TABLE ACCESSORY JEB MIZUHO ORTHOPEDIC SYSTEMS, INC. 5358

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK