BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON

    MDR report key: 8277169 · Received January 25, 2019

    Report

    Report Number
    8277169
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    November 1, 2018
    Report Date
    January 3, 2019
    Manufacturer
    STRYKER CORPORATION
    Product Code
    KIJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STRYKER HUDSON MODIFIED TRINKLE (PART# 6203-135) IS DIFFICULT TO DECONTAMINATE BECAUSE OF THE DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70771 HUDSON INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER CORPORATION 6203-135 -

    Patients

    Seq Age Sex Outcome Treatment
    1