BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCL SPLINT ROLL

    MDR report key: 17381 · Received September 19, 1994

    Report

    Report Number
    17381
    Event Type
    Malfunction
    Date Received
    September 19, 1994
    Date of Event
    May 17, 1992
    Report Date
    August 30, 1994
    Manufacturer
    ORTHOPEDIC CASTING LAB, INC.
    Product Code
    LGF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE EMERGENCY DEPT WITH SPRAINED RIGHT ANKLE. A CAST WAS APPLIED 5/17/92. PT RETURNED 5/18/92 WITH A 2 DEGREE BURN TO LOWER BACK OF RIGHT LEG. PT COMPLAINED OF "BURNS TO LEG BECAUSE CAST WAS TOO HOT". THIS COMMENT WAS MADE AT TIME OF RETURN VISIT TO THE EMERGENCY DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCL SPLINT ROLL SPLINT/CASTING MATERIAL LGF ORTHOPEDIC CASTING LAB, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other NOT AVAILABLE AT THIS TIME.