BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PRO GI

    MDR report key: 7464206 · Received April 26, 2018

    Report

    Report Number
    3005099803-2018-01401
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Report Date
    March 31, 2018
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 28 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012013, 17 COMPLAINT DEVICES WERE RETURNED, 7 COMPLAINT DEVICES WERE DISPOSED, AND 4 COMPLAINT DEVICES WERE NOT RETURNED. SIX EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT, AND 7 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF SUPPLIER DESIGN. INVESTIGATION IS STILL IN PLACE FOR 4 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 28 REPORTED EVENTS OF BALLOONS BURSTS/PINHOLES. OF THE EVENTS, 3 PATIENTS WERE FEMALE AND 5 WERE MALE. THE KNOWN PATIENTS' AGES RANGED FROM 49 YEARS TO 62 YEARS. THE KNOWN PATIENTS' WEIGHTS RANGED FROM 52 KG TO 66 KG. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307799 CRE PRO GI DILATOR, ESOPHAGEAL KNQ M00558790

    Patients

    Seq Age Sex Outcome Treatment
    1