BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 7228532 · Received January 30, 2018

    Report

    Report Number
    3005099803-2018-00227
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Report Date
    January 1, 2018
    Product Code
    KNQ
    PMA / PMN Number
    K110833
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 26 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012013, 19 COMPLAINT DEVICES WERE RETURNED, 2 COMPLAINT DEVICES WERE DISPOSED, AND 5 COMPLAINT DEVICE WAS NOT RETURNED. 6 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT, 10 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF SUPPLIER DESIGN, AND 1 EVENT WAS FOUND TO HAVE A ROOT CAUSE OF USER ERROR. INVESTIGATION IS STILL IN PLACE FOR 2 EVENTS.

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012013 FOR PRODUCT CODE KNQ. THIS REPORT COVERS 26 REPORTED EVENTS OF BALLOONS BURSTS/PINHOLES. OF THE EVENTS, 1 PATIENT WAS FEMALE AND 5 WERE MALE. THE KNOWN PATIENTS' AGES RANGED FROM 56 YEARS TO 73 YEARS. THE KNOWN PATIENTS' WEIGHTS RANGED FROM 57 KG TO 62 KG. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71920 CRE¿ WIREGUIDED DILATOR, ESOPHAGEAL KNQ M00558500

    Patients

    Seq Age Sex Outcome Treatment
    1