BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIZUHO OSI

    MDR report key: 7545114 · Received May 25, 2018

    Report

    Report Number
    2921578-2018-00020
    Event Type
    Injury
    Date Received
    May 25, 2018
    Report Date
    July 16, 2018
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO DETERMINE HOW MANY PATIENTS MAY HAVE BEEN AFFECTED, WHETHER ANY OF THE INJURIES WERE SEVERE, OR WHAT PRODUCTS WERE BEING USED. PROVIDED EDUCATION ON PROPER EQUIPMENT SELECTION, PATIENT POSITIONING, AND USE OF DISPOSABLES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MIZUHO OSI; WE ARE HAVING SEEMINGLY INCREASED INCIDENCES OF FACIAL BLISTERING, CHEST AND ILIAC CREST POST-OP REDNESS AND PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO (B)(4); WE ARE HAVING SEEMINGLY INCREASED INCIDENCES OF FACIAL BLISTERING, CHEST AND ILIAC CREST POST-OP REDNESS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388155 MIZUHO OSI SURGICAL TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other