BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A-TRAC

    MDR report key: 927654 · Received September 5, 2007

    Report

    Report Number
    927654
    Event Type
    Injury
    Date Received
    September 5, 2007
    Date of Event
    August 13, 2007
    Report Date
    September 5, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS OPERATING A LAPAROSCOPIC BABCOCK. THE INSERT BROKE OFF INSIDE THE PATIENT. THE INSERT WAS RETRIEVED AND TAKEN OUT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-TRAC INSTRUMENT, SURGICAL, LAPAROSCOPIC BABCOCK GCJ APPLIED MEDICAL RESOURCES CORP. A-TRAC 1036431

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention