BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN ORTHOPAEDIC

    MDR report key: 2992557 · Received February 27, 2013

    Report

    Report Number
    2992557
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BSN MEDICAL, INC
    Product Code
    LGH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PHYSICAL THERAPIST (PT) WAS OPENING A WINDOW ON THE CAST ON THE RIGHT LEG ON THE ANTERIOR PORTION OF THE ANKLE. THE CAST SAW APPARENTLY WAS ALLOWED TO CONTACT THE SKIN WHICH RESULTED IN A SMALL RED AREA AND SMALL OPEN AREA. THE PHYSICIAN ASSISTANT WAS CONTACTED AND THE WOUNDS WERE TREATED AND A BANDAGE APPLIED. ON TUESDAY, A DIFFERENT DRESSING WAS ORDERED BY THE PHYSICIAN. ON WEDNESDAY, A 2ND CAST WAS APPLIED AND A WINDOW CREATED TO VIEW THE WOUND. THREE SMALL HORIZONTAL LINEAR RED AREAS WERE NOTED AND THE TOP ONE HAD A SMALL OPEN AREA. THE BOTTOM TWO AREAS ARE LIKELY THE RESULT OF THE STOCKING MATERIAL WRINKLING UNDER THE CAST, OR THE EDGE OF THE CAST AND THE TOP ONE AS A RESULT OF THE CAST COMING IN CONTACT WITH THE SKIN. THE AREA WAS CLEANED AND A TOPICAL ANTIBACTERIAL APPLIED AND MEPILEX DRESSING APPLIED PRIOR TO CASTING. ON THURSDAY MORNING, THE PHYSICIAN ASSESSED THE WOUND AND NOTED THAT THE PATIENT WAS COMPLAINING OF PRESSURE AND PAIN IN THE AREA ABOVE THE WOUND - LIKELY A RESULT OF THE CAST BEING TOO TIGHT. THE CAST WAS REMOVED BY THE PT. REHAB EDUCATOR TO DEVELOP COMPETENCY REVIEWS FOR SERIAL CASTING FOR OUR DEPT. SERIAL CASTING IS INFREQUENTLY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83531 AMERICAN ORTHOPAEDIC SAW LGH BSN MEDICAL, INC 0295-200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR