BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 6980449 · Received October 26, 2017

    Report

    Report Number
    3005099803-2017-03247
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Report Date
    October 1, 2017
    Product Code
    KNQ
    PMA / PMN Number
    K110833
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 39 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012013, 32 COMPLAINT DEVICES WERE RETURNED, 6 COMPLAINT DEVICES WERE DISPOSED, AND 1 COMPLAINT DEVICE WAS NOT RETURNED. THIRTEEN EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT, 1 EVENT WAS FOUND TO HAVE A ROOT CAUSE OF HANDLING, 14 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 3 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 39 REPORTED EVENTS OF BALLOONS BURSTS/PINHOLES. OF THE EVENTS, 1 PATIENT WAS FEMALE AND 10 WERE MALE. THE KNOWN PATIENTS' AGES RANGED FROM 32 YEARS TO 81 YEARS. THE KNOWN PATIENTS' WEIGHTS RANGED FROM 58 KG TO 68 KG. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760784 CRE¿ WIREGUIDED DILATOR, ESOPHAGEAL KNQ M00558420

    Patients

    Seq Age Sex Outcome Treatment
    1