BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN ORTHOPEDIC

    MDR report key: 23132237 · Received September 24, 2025

    Report

    Report Number
    23132237
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    May 1, 2025
    Report Date
    August 8, 2025
    Manufacturer
    BSN MEDICAL, INC.
    Product Code
    LGH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO PRE-OP AREA WITH CAST ON THE OPERATIVE ARM. MD GAVE ORDERS TO REMOVE CAST WITH CAST SAW. NURSE OBTAINED CAST SAW AND BEGAN TO REMOVE THE CAST. NURSE HAD ONLY BEEN USING THE SAW FOR LESS THAN A MINUTE WHEN THE PATIENT STATED HE FELT IT GETTING HOT LIKE IT WAS BURNING. UPON REMOVAL OF THE CAST, THERE WERE TWO AREAS THAT APPEARED TO HAVE BEEN AFFECTED ON R [RIGHT] FOREARM. 1 VERTICAL 1.02 CM LONG, SUPERFICIAL; 0.2 CM SMALL ABRASION AND TRANSVERSE ERYTHEMA 2X3CM ON INNER WRIST. MD MADE AWARE AND STATED HE WOULD ASSESS AND TREAT, IF NEEDED, IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641794 AMERICAN ORTHOPEDIC INSTRUMENT, CAST REMOVAL, AC-POWERED LGH BSN MEDICAL, INC. 0295-200

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Other