BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 PC SST SET W/BASE

    MDR report key: 7691612 · Received July 16, 2018

    Report

    Report Number
    2921578-2018-00026
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    January 31, 2018
    Report Date
    September 19, 2018
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PADS WERE DISPOSED AND UNKNOWN IF THEY WERE MADE OUT OF SPECIFICATION. THE PAD IN QUESTION ARE NO LONGER MANUFACTURED BY MIZUHO OSI.

    Description of Event or Problem · 0

    INDICATES PAD ARE "TOO HARD" AND CAUSED A NUMBER OF PATIENT'S LOWER EXTREMITY PAIN & NUMBNESS FOR EXTENDED PERIOD POST-SURGERY. THE MATERIAL OF THE PADS WOULD NOT SOFTEN ADEQUATELY EVEN WHEN WARMED.

    Description of Event or Problem · 1

    INDICATES PAD ARE "TOO HARD" AND CAUSED A NUMBER OF PATIENT'S LOWER EXTREMITY PAIN & NUMBNESS FOR EXTENDED PERIOD POST-SURGERY. THE MATERIAL OF THE PADS WOULD NOT SOFTEN ADEQUATELY EVEN WHEN WARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532074 8 PC SST SET W/BASE PADS JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6957

    Patients

    Seq Age Sex Outcome Treatment
    1 Other