BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-SPLINT 3INX15LYRX20FT

    MDR report key: 315292 · Received February 9, 2001

    Report

    Report Number
    1818910-2001-00052
    Event Type
    Injury
    Date Received
    February 9, 2001
    Date of Event
    January 10, 2001
    Report Date
    February 9, 2001
    Manufacturer
    DEPUY-PUERTO RICO, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    FYH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED 2ND DEGREE BURNS. THEY WANT TO KNOW WHAT CHEMICALS ARE IN THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5053 J-SPLINT 3INX15LYRX20FT CASTING PRODUCT FYH DEPUY-PUERTO RICO, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other