BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRILE WOOD NDL HLDR 6" DJ

    MDR report key: 369272 · Received January 3, 2002

    Report

    Report Number
    1423507-2002-00001
    Event Type
    Injury
    Date Received
    January 3, 2002
    Date of Event
    October 10, 2001
    Report Date
    January 3, 2002
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    FHQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING SPECIALTY NEEDLE HOLDERS TO MANIPULATE TISSUE, THE LUNGSTEN CARBIDE INSERT SEPARATED AND THE INSERT WAS LEFT IN TH PT'S CAVITY REQUIRING SURGICAL INTERVENTION TO REMOVE. THIS WAS IDENTIFIED TWO WEEKS AFTER THE INITIAL SURGERY BY X-RAY DURING A FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRILE WOOD NDL HLDR 6" DJ INSTRUMENT FHQ ALLEGIANCE HEALTHCARE CORP. SU16005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention