BEUDAMED
    FDA Adverse Event Injury Summary report: N

    #1 SUPER SPLINT

    MDR report key: 399179 · Received June 10, 2002

    Report

    Report Number
    2921578-2002-00002
    Event Type
    Injury
    Date Received
    June 10, 2002
    Date of Event
    April 22, 2002
    Report Date
    June 5, 2002
    Manufacturer
    M-PACT
    Product Code
    ILZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REQUIRED SPLINTING FOR TRACTION OF LEFT ANKLE FRACTURE, AFTER SPLINTING MATERIAL WAS APPLIED AND CASTED LEG WAS SURROUNDED BY PILLOW FOR POSITIONING. PT COMPLAINED OF EXTREME HEAT. SECOND DEGREE BURNS NOTED BY FACILITY AFTER PT WAS TRANSFERRED TO O.R. FOR SURGERY. CONTACT WITH THE HOSPITAL ALLOWED FOR DETERMINATION THAT DURING PLACEMENT OF SPLINT, THE PT COMPLAINED OF EXCESSIVE HEAT. HEALTHCARE WORKERS DISREGARDED SPECIFIC INSTRUCTIONS FOR USE ON DEVICE AND COMPLAINTS FROM PT AND KEPT DEVICE ON PT. BURNS DISCOVERED BY SURGEON AFTER PT WAS TRANSFERRED TO HOSPITAL. PRODUCT WAS FOUND TO HAVE PERFORMED TO MANUFACTURING SPECIFICIATIONS AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 #1 SUPER SPLINT FOAM AND FLANNEL SPLINTING SYSTEM ILZ M-PACT 2862 1283

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization