BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN ORTHOPAEDIC CAST CUTTER - HEX DRIVE

    MDR report key: 20770986 · Received November 25, 2024

    Report

    Report Number
    20770986
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 9, 2024
    Manufacturer
    BSN MEDICAL, INC.
    Product Code
    LGH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE REMOVING CASTS FROM A SERIAL CASTING PATIENT, SHE JUMPED AND STATED IT WAS HOT. UPON COMPLETION OF CAST REMOVAL, SKIN WAS INSPECTED AND SHE DID HAVE A SMALL BURN. THE CAST SAW BLADES BECAME VERY HOT AND THE BURN OCCURRED THROUGH STOCKINETTE BARRIER AND SEVERAL LAYERS OF WEBRIL CAST PADDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631306 AMERICAN ORTHOPAEDIC CAST CUTTER - HEX DRIVE INSTRUMENT, CAST REMOVAL, AC-POWERED LGH BSN MEDICAL, INC. 74470-00010-01

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Other