BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALUMINUM CRUTCHES

    MDR report key: 2818484 · Received October 26, 2012

    Report

    Report Number
    1417592-2012-00093
    Event Type
    Other
    Date Received
    October 26, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER WAS USING CRUTCHES FOLLOWING AN ACL REPAIR. IT WAS REPORTED THAT THE HAND GRIP BROKE AND THE CRUTCH TIPS WORE THROUGH, CAUSING THE END USER TO SLIP AND LOSE HIS BALANCE. HE APPARENTLY FELL AND SUFFERED A LEG FRACTURE. NO OTHER DETAILS PERTAINING TO THE INCIDENT OR THE END USER WERE PROVIDED. THE SAMPLE WAS RETURNED AND EVALUATED. ONE OF THE TWO CLASPS WAS MISSING FROM THE HAND GRIP OF ONE CRUTCH. IT IS NOT KNOWN WHAT HAPPENED TO THE CLASP. THE ACTUAL HAND GRIP HAD NO VISIBLE DAMAGE, REMAINED IN PLACE WITH THE REMAINING CLASP AND MAINTAINED A LEVEL OF WEIGHT BEARING CAPACITY SUITABLE FOR NORMAL USAGE. THE CRUTCH TIPS WERE EXTREMELY WORN AND THE CRUTCH EXTENSION LEG WAS VISIBLE THROUGH A TEAR IN ONE OF THE TIPS. DIRT WAS FOUND ON THE INSIDE EDGES OF THE TORN TIP, INDICATING IT HAD BEEN USED FOR A PERIOD OF TIME AFTER THE TIP INTEGRITY WAS COMPROMISED. TAPE WAS FOUND WRAPPED AROUND THE CRUTCH EXTENSION LEG, IMMEDIATELY ABOVE THIS TORN CRUTCH TIP. THE PRESENCE AND LOCATION OF THE TAPE SUGGESTS IT HAD BEEN PLACED TO PREVENT THE MOVEMENT OF THE TIP UPWARD ON THE CRUTCH EXTENSION LEG DURING USE. THE INSTRUCTIONS STATE THAT BEFORE EACH USE, THE CRUTCH TIPS SHOULD BE INSPECTED TO ASSURE THEY ARE IN GOOD CONDITION AND THAT THEY SHOULD BE REPLACED IMMEDIATELY WHEN WORN. THE SAMPLE EVALUATION SUGGESTS THE CRUTCH WAS USED WITH A SELF-REPAIRED AND DAMAGED TIP.

    Description of Event or Problem · 1

    THE END USER FELL WHILE AMBULATING WITH THE CRUTCHES AND FRACTURED HIS LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINUM CRUTCHES IPS MEDLINE INDUSTRIES, INC. E120520484

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other