BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVON

    MDR report key: 7145617 · Received December 26, 2017

    Report

    Report Number
    9612030-2017-05260
    Event Type
    Malfunction
    Date Received
    December 26, 2017
    Report Date
    March 21, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FZZ
    UDI-DI
    10884527016006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT. THE COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. THE REPORTED CONDITION BY THE CUSTOMER COULD NOT BE CONFIRMED WITHOUT A PHYSICAL SAMPLE OR PHOTOGRAPH TO ANALYZE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THE ROOT CAUSE FOR THE REPORTED CONDITION CANNOT BE SPECIFICALLY IDENTIFIED WITHOUT A REPRESENTATIVE SAMPLE; THEREFORE, CORRECTIVE ACTION WILL BE LIMITED TO THE MANUFACTURING AWARENESS THIS TIME. THE CURRENT PROCESS IS RUNNING ACCORDING TO PRODUCT SPECIFICATIONS MEETING QUALITY ACCEPTANCE CRITERIA. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 12/26/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE TEAM HAS FOUND OUR SURGICAL MARKERS TO BE BLEEDING AND LEAVING A JAGGED LINE FOR THE INCISION PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925547 DEVON MARKER, SKIN FZZ COVIDIEN 31145827 1715777464 10884527016006

    Patients

    Seq Age Sex Outcome Treatment
    1