BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ PULMONARY

    MDR report key: 6980445 · Received October 26, 2017

    Report

    Report Number
    3005099803-2017-03248
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Report Date
    October 1, 2017
    Product Code
    KTI
    PMA / PMN Number
    K023337
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 1 EVENT REPORTED UNDER EXEMPTION NUMBER E2012010, THE PRODUCT HAS BEEN RETURNED BUT ANALYSIS HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012010 FOR PRODUCT CODE KTI. THIS REPORT SUMMARIZES 1 REPORTED EVENT OF BALLOON LEAK. IT WAS REPORTED THAT THE PATIENT WAS OVER 18 YEARS OF AGE. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759947 CRE¿ PULMONARY BRONCHOSCOPE ACCESSORY KTI M00550310

    Patients

    Seq Age Sex Outcome Treatment
    1