BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTM ACCLM ULNA W HOLES STD RT

    MDR report key: 505777 · Received January 9, 2004

    Report

    Report Number
    1818910-2004-00017
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    December 10, 2003
    Report Date
    December 10, 2003
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS LABELED INCORRECTLY. SURGERY WAS DELAYED ONE HOUR AND THE PT HAS A BROKEN BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CTM ACCLM ULNA W HOLES STD RT EXTREMITIES KWJ DEPUY ORTHOPAEDICS, INC. NA X5BFB1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention