BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL UNKNOWN

    MDR report key: 2684859 · Received August 3, 2012

    Report

    Report Number
    3003898360-2012-00277
    Event Type
    Malfunction
    Date Received
    August 3, 2012
    Report Date
    July 5, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRAND NAME AND COMMON DEVICE NAME WAS NOT PROVIDED BY THE INITIAL REPORTER. THE LOT NUMBER (1100290) PROVIDED BY THE INITIAL REPORTER COULD NOT BE VALIDATED IN OUR SYSTEM. THE CATALOG NUMBER (543295) PROVIDED BY THE INITIAL REPORTER COULD NOT BE VALIDATED IN OUR SYSTEM. SEVERAL ATTEMPTS (VIA PHONE MESSAGES) TO THE INITIAL REPORTER WERE MADE TO OBTAIN ADDITIONAL INFO AND CLARIFICATION OF CATALOG NUMBER AND LOT NUMBER. NO RESPONSE FROM THE INITIAL REPORTER, NO DATE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: APPLIER WOULD NOT CLOSE ON A VESSEL. NO PT INJURY REPORTED. ADDITIONAL INFO REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL UNKNOWN UNKNOWN GDT TELEFLEX MEDICAL 1100290

    Patients

    Seq Age Sex Outcome Treatment
    1