BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFINS

    MDR report key: 9207799 · Received October 18, 2019

    Report

    Report Number
    9207799
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    December 21, 2018
    Report Date
    September 16, 2019
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    YELLOWFIN STIRRUP- THIS IS A POSITIONING DEVICE. THE DEVICE DRIFTED INWARD DURING CASE- IT HAS BEEN SENT OUT FOR REPAIR. IT WAS USED FOR 2 PROCEDURES AND IT HAPPENED BOTH TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004726 YELLOFINS SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1