BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFINS STIRRUP

    MDR report key: 10000438 · Received April 27, 2020

    Report

    Report Number
    10000438
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    November 22, 2019
    Report Date
    April 21, 2020
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RIGHT LEG STIRRUP CAME OUT OF BRACKET WITH PATIENT'S LEG IN THE STIRRUP. THE STIRRUP CAME OUT OF THE STIRRUP HOLDER DURING SURGERY. SURGEON WAS STANDING NEXT TO LEG AND WAS ABLE TO HOLD LEG AND IT WAS AT THE END OF THE CASE. NO HARM TO THE PATIENT. BIOMED TECH TESTED YELLOFINS STIRRUPS. CONNECTED BOTH BRACKETS TO SURGERY BED. BRACKETS TIGHT AND STIRRUP WAS MOVED TO DIFFERENT DIRECTIONS. UNIT WAS STEADY WITH NO ISSUES. STIRRUPS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464230 YELLOFINS STIRRUP SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS, INC. O-YFASI

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA