BEUDAMED
    FDA Adverse Event Other Summary report: N

    @CRUTCH, ALUMINUM, ADULT MEDIU

    MDR report key: 1628828 · Received March 5, 2010

    Report

    Report Number
    1417592-2010-00004
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 11, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IPR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    END USER HAS BEEN A RIGHT LEG AMPUTEE FOR 38 YEARS. SHE DOES NOT WEAR A PROSTHESIS. SHE REPORTED THAT SHE WAS GETTING OUT OF THE CAR WITH THE SUPPORT OF CRUTCHES WHEN SUDDENLY ONE BROKE AND SHE FELL. THE TOP PIN WHICH CONNECTS THE WING TUBES TO THE ADJUSTMENT TUBE WAS MISSING. SHE DOES NOT KNOW WHAT HAPPENED TO IT BUT WAS SURE IT HAD BEEN THERE. SHE WENT TO THE EMERGENCY ROOM AND REPORTS SHE SPRAINED HER HIP AND HAND/WRIST. SHE HAD A CAST ON HER HAND THAT WAS SUBSEQUENTLY REMOVED. THE SAMPLE WAS RECEIVED AND EVALUATED. CONFIRMED THE CRUTCH IS MISSING THE RIVET AT THE TOP OF THE WING TUBE/LEG TUBE CONNECTION. THE SAMPLE HAS SCRATCHES ALL UP AND DOWN ONE SIDE OF IT. THIS COULD INDICATE POSSIBLE SOURCE OF DAMAGE TO THE RIVET. THE CRUTCH IS SCRATCHED ALONG THE ENTIRE CONTOUR OF THE WING TUBE, AND THE SCRATCHES ARE ELONGATED, INDICATING IT WAS DRAGGED ACROSS SOMETHING, NOT DROPPED ONTO THE GROUND. THE RIVET WAS NOT INCLUDED WITH THE SAMPLE, AS IT WAS LOST DURING THE FALL. FROM THE MARKINGS AROUND THE RIVET HOLES, IT WAS CONFIRMED THAT IT WAS INDEED THERE AT ONE POINT. THE CRUTCH SHOWS NO SIGN OF MANUFACTURING DEFECT OR MATERIAL DEFECT. WITHOUT THE RIVET, WE CANNOT DETERMINE THE ROOT CAUSE OF THE INCIDENT. BESIDES THE SCRATCHES UP AND DOWN ONE SIDE OF THE CRUTCH, IT IS OTHERWISE RELATIVELY NEW LOOKING. THE TIP HAS ONLY MINOR WEAR AND IT IS EVEN.

    Description of Event or Problem · 1

    END USER REPORTED THAT CRUTCH BROKE AS SHE WAS GETTING OUT OF A CAR. THE FALL RESULTED IN A SPRAIN TO HER WRIST AND HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 @CRUTCH, ALUMINUM, ADULT MEDIU NONE IPR MEDLINE INDUSTRIES, INC. MDSV80535 E090961585

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other