BEUDAMED
    FDA Adverse Event Other Summary report: N

    YELLOFIN STIRRUP

    MDR report key: 1918171 · Received December 3, 2010

    Report

    Report Number
    1221538-2010-00009
    Event Type
    Other
    Date Received
    December 3, 2010
    Report Date
    November 5, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DECLINED TO PROVIDE ANY INFORMATION CONCERNING THE PT'S STATUS OR IF AN INJURY RESULTED. THE ALLEN ENGINEER EVALUATED THE RETURN TO DETERMINE IF THERE WERE ANY DEVICE ISSUES THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT ASIDE FROM IMPROPER INSTALLATION. THE (B)(6) STIRRUP WAS WORN AND DID NOT PASS ALL DEVICE SPECIFICATIONS BUT THE FAILURE DESCRIBED COULD NOT BE REPLICATED IF THE STIRRUP AND THE CLAMP WERE PROPERLY INSTALLED. THE CUSTOMER WAS INFORMED OF THE INVESTIGATION OUTCOME AND PROVIDED USER INSTRUCTIONS FOR BOTH THE CLAMPS AND THE STIRRUPS AND AN ALLEN REP IS WORKING WITH THE STAFF.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A PT INCIDENT WAS REPORTED TO AN ALLEN MEDICAL SALES REP DURING A REQUEST FOR TRAINING INFORMATION. IT WAS UNCLEAR IF THE PT WAS INJURED. THE REPORTER TOLD THE REP THAT DURING USE, THE STIRRUP CAME FREE OF THE CLAMP INSTALLED ON THE TABLE RAIL. THE PT'S LEG FELL. THE REPORTER WAS SEEKING TRAINING INFORMATION TO HELP PREVENT ANOTHER SUCH ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YELLOFIN STIRRUP LOW PROFILE STIRRUP, YELLOFIN STIRRUP FWZ ALLEN MEDICAL SYSTEMS O-YFASI-A4

    Patients

    Seq Age Sex Outcome Treatment
    1