BEUDAMED
    FDA Adverse Event Summary report: N

    5840-7569

    MDR report key: 2573247 · Received March 26, 2012

    Report

    Report Number
    2921578-2012-00004
    Date Received
    March 26, 2012
    Report Date
    March 19, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACTED HOSPITAL MULTIPLE TIMES ABOUT INCIDENT AND PT OUTCOME (EMAIL, PHONE, VISIT), HOSPITAL FAILED TO RESPOND TO INITIAL COMPLAINT, CLOSE OF COMPLAINT DUE TO NO RESPONSE.

    Description of Event or Problem · 1

    CUSTOMER NOTIFIED COMPANY THAT DURING THE USE OF THE MIZUHO OSI TEMPUR MED CHEST PAD, THE PT "KID", HAD SHOWN SIGNS OF BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5840-7569 TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC POWERED JEA JEA MIZUHO OSI 5840-7569 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other