BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS YELLOFIN STIRRUP

    MDR report key: 601548 · Received May 11, 2005

    Report

    Report Number
    1221538-2005-00003
    Event Type
    Injury
    Date Received
    May 11, 2005
    Date of Event
    April 6, 2005
    Report Date
    April 11, 2005
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A PT EXPERIENCED A TEMPORARY PARALYSIS FOLLOWING A PROCEDURE IN THE STIRRUPS. THE COMPLAINANT STATED THAT IT WAS A LONG PROCEDURE AND MIDWAY THROUGH THE PROCEDURE THE USER REPOSITIONED THE STIRRUPS AND LIKELY INADVERTENTLY LOOSENED THE BOOT LOCKING HANDLE. THIS LOOSE BOOT CONDITION WAS NOTICED BY THE CAREGIVERS AND IT RESULTED IN THE HYPEREXTENSION OF THE PT'S LEG CAUSING A TEMPORARY PARALYSIS NOTED AT THE CONCLUSION OF THE PROCEDURE. THE COMPLAINANT STATED THAT THEY BELIEVED THIS TO BE CAUSED BY A USER ERROR. THE COMPLAINANT REQUESTED THE LOCAL COMPANY REPRESENTATIVE TO INSPECT THE STIRRUPS WHICH THEY DID, AND FOUND ALL THREE SETS USED IN THE OR TO BE IN GOOD WORKING ORDER. IT COULD NOT BE DETERMINED WHICH SET HAD BEEN USED IN THIS PARTICULAR PROCEDURE. DUE TO THE ADVERSE IMPACT ON THE PT, THE PT'S HOSPITALIZATION WAS EXTENDED AND AN ADDITIONAL TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS YELLOFIN STIRRUP PATIENT POSITIONING DEVICE FWZ ALLEN MEDICAL SYSTEMS O-YFSI-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention