BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKERS

    MDR report key: 802784 · Received January 3, 2007

    Report

    Report Number
    3002698551-2006-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Date of Event
    December 18, 2006
    Report Date
    December 22, 2006
    Manufacturer
    PRAXIM
    Product Code
    HAW
    PMA / PMN Number
    K031196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS REPORT DOES NOT CONCERN THE NAVIGATION SYSTEM CLEARED UNDER #K031196 BUT ONLY ONE OF THE ACCESSORIES, DELIVERED AS STERILE DISPOSABLES. ADDITIONAL LOT # 0604040, ADDITIONAL EXP DATE: 07/2011.

    Description of Event or Problem · 1

    THIS REPORTING FOLLOWS THE INFORMATION OF A CUSTOMER, USING STERILE DISPOSABLE NAMED "MARKERS". WE SUSPECT THE NON-AIRTIGHNESS OF A SEAL ON "TYVEK" SACHET CONTAINING STERILE MARKERS. AFTER INVESTIGATION , PRAXIM, THE MANUFACTURER, IDENTIFIED A PROBLEM IN THE WELDING PROCESS OF THOSE BAGS. THIS DOES NOT ALLOW US TO BE CONFIDENT IN THE AIR IMPERMEABILITY OF THE BAGS. A BRIEF DESCRIPTION OF THE USE OF THE DEVICE AND THE DISPOSABLE IS AVAILABLE IN THE ATTACHED REPORT. THESE MARKERS ARE USED AS DISPOSABLE IN THE NAVIGATION SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARKERS MARKERS HAW PRAXIM PPX-8220 0607112

    Patients

    Seq Age Sex Outcome Treatment
    1 *