BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 2181647 · Received July 12, 2011

    Report

    Report Number
    2181647
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE 6 INDIVIDUAL PACKAGES WERE RETRIEVED FROM STOCKED CABINETS. THE SURGEON, NURSE, AND SCRUB TECH ALL REVIEWED THE PACKAGING LABELS FOR CORRECT SIZE, SIDE, ETC. THE PACKAGE LABEL WORDING FONT FOR THIS BRAND OF PRODUCT IS SMALL, THE INFORMATION IS NOT CONSISTENTLY IN THE SAME AREA ON EACH COMPONENT'S BOX, AND IS NOT CODED IN ANY WAY, WHICH CAN ALLOW FOR HUMAN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. * C53AK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R NO OTHER THERAPIES