BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALUMINUM CRUTCHES

    MDR report key: 2862336 · Received November 8, 2012

    Report

    Report Number
    1417592-2012-00095
    Event Type
    Other
    Date Received
    November 8, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IPR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER REPORTED THAT HE WAS AMBULATING INSIDE HIS HOME AND THAT HE FELL WHEN A CRUTCH TIP WORE THROUGH ONE OF THE CRUTCHES. HE WAS DIAGNOSED WITH A LUMBAR SPRAIN AND WAS TREATED WITH PHYSICAL THERAPY, A MUSCLE RELAXANT AND PAIN MEDICATION. THE END USER DID NOT RETURN THE SAMPLE TO US FOR EVALUATION. NO PHOTOS WERE SENT. WE HAVE NOT CONFIRMED THE ISSUE OR IDENTIFIED A POTENTIAL ROOT CAUSE. THE OVERALL CARE AND CONDITION OF THE CRUTCHES IS NOT KNOWN. WARNINGS IN THE OWNER'S MANUAL STATE THAT BEFORE EACH USE, THE END USER SHOULD MAKE SURE THE TIPS ARE IN GOOD CONDITION AND THAT THEY SHOULD BE REPLACED IMMEDIATELY WHEN WORN. DUE TO THE REPORTED INJURY AND NEED FOR MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE END USER FELL WHILE AMBULATING WITH CRUTCHES AND SUFFERED A LUMBAR SPRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINUM CRUTCHES IPR MEDLINE INDUSTRIES, INC. N110944844

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other