BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTATIX

    MDR report key: 2912997 · Received January 8, 2013

    Report

    Report Number
    2912997
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 8, 2013
    Manufacturer
    HEMOSTATIX MEDICAL TECHNOLOGIES, LLC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SURGICAL PENCIL THAT WAS BEING USED DURING AN ELECTROCAUTERY PROCEDURE CAME APART DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10224 HEMOSTATIX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI HEMOSTATIX MEDICAL TECHNOLOGIES, LLC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *