BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-SPLINT 6INX15LYRX20FT

    MDR report key: 444861 · Received February 26, 2003

    Report

    Report Number
    1818910-2003-00106
    Event Type
    Injury
    Date Received
    February 26, 2003
    Date of Event
    January 17, 2003
    Report Date
    February 26, 2003
    Manufacturer
    DEPUY-NORTH BRUNSWICK, CASTINGS PRODUCTS DIVISION
    Product Code
    FYH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHILE SPLINTING AN ELBOW; THE PATIENT COMPLAINED IT WAS TOO HOT. THE PATIENT RECEIVED SECOND DEGREE BURNS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-SPLINT 6INX15LYRX20FT CASTING PRODUCT FYH DEPUY-NORTH BRUNSWICK, CASTINGS PRODUCTS DIVISION NA 28290#17

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention