BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRUTCH, ALUMINUM, ADULT, TALL, LF 300LB

    MDR report key: 1884987 · Received October 22, 2010

    Report

    Report Number
    1417592-2010-00065
    Event Type
    Other
    Date Received
    October 22, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IPR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER REPORTED THAT HE WAS WALKING ON CONCRETE TOWARDS HIS CAR. HE STATES THAT THE CRUTCH BENT OUTWARD AND HE FELL, FRACTURING HIS WRIST AND TEARING LIGAMENTS IN HIS SHOULDER. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE SENT FOR REVIEW. THE ISSUE HAS NOT BEEN CONFIRMED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. NO TREND EXISTS FOR THIS PRODUCT OR THIS ISSUE. HOWEVER, DUE TO THE REPORTED WRIST FRACTURE, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE END USER WAS AMBULATING OUTSIDE. HE REPORTED THAT ONE CRUTCH BENT, CAUSING HIM TO FALL. HE SUSTAINED A FRACTURED WRIST AND TORN LIGAMENTS IN HIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRUTCH, ALUMINUM, ADULT, TALL, LF 300LB NONE IPR MEDLINE INDUSTRIES, INC. MDSV80534 T091218145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other