BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN COLORECTAL STIRRUPS

    MDR report key: 14512341 · Received May 26, 2022

    Report

    Report Number
    14512341
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 9, 2022
    Report Date
    May 10, 2022
    Manufacturer
    ALLEN MEDICAL SYSTEM, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT IN LITHOTOMY POSITION IN YELLOW FIN STIRRUPS. TOWARDS END OF PROCEDURE STIRRUPS WERE REPOSITIONED BY THE DOCTOR AFTER REMOVING THE FOLEY CATHETER. DURING THIS STANDARD STIRRUP MANIPULATION, THE RIGHT STIRRUP FELL OFF THE BED. THE CLAMP HOLDING THE YELLOWFIN STIRRUP ON THE BED APPEARED TO HAVE BROKEN. THE PATIENT¿S LEG WAS IMMEDIATELY REMOVED FROM THE STIRRUP AND PATIENT WAS PLACE IN SUPINE POSITION. THE DOCTOR ORDERED AN X-RAY OF THE RIGHT HIP AND RIGHT KNEE. CHARGE PACU RN WAS ALSO NOTIFIED OF THE INCIDENT TO EVALUATE THE PATIENT¿S CONDITION. THE DOCTOR SAID SHE WAS NOTIFYING RISK MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091176 ALLEN COLORECTAL STIRRUPS SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEM, INC. O-YFSI-L-A5

    Patients

    Seq Age Sex Outcome Treatment
    1 10220 DA Female