BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAROT NEEDLE HOLDER

    MDR report key: 2082488 · Received April 29, 2011

    Report

    Report Number
    2082488
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    MJG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN WAS USING THE NEEDLE HOLDER IN THE HEART AND NOTICED A SECTION OF THE JAW INSERT WAS MISSING. THE STERILE FIELD AND FLOOR WERE SEARCHED, BUT IT WAS NOT FOUND. PATIENT WAS SEARCHED WITH X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAROT NEEDLE HOLDER SAROT NEEDLE HOLDER MJG CODMAN & SHURTLEFF, INC. 36-3020 *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR