BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFIN STIRRUPS

    MDR report key: 8273169 · Received January 24, 2019

    Report

    Report Number
    8273169
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    December 21, 2018
    Report Date
    January 2, 2019
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    YELLOFIN STIRRUP- THIS IS A POSITIONING DEVICE. THE DEVICE DRIFTED INWARD DURING CASE. IT HAS BEEN USED FOR TWO PROCEDURES AND IT HAPPENED BOTH TIMES. IT HAS BEEN SENT TO VENDOR FOR REPAIR. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68345 YELLOFIN STIRRUPS SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1