BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA¿

    MDR report key: 6982933 · Received October 27, 2017

    Report

    Report Number
    3005099803-2017-03297
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Report Date
    October 1, 2017
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THIS EVENT RELATED TO EXEMPTION NUMBER E 2012012, IT WAS DETERMINED TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012012 FOR PRODUCT CODE EZN. THIS REPORT SUMMARIZES 1 EVENT REPORTED TO BOSTON SCIENTIFIC FOR UROMAX ULTRA BALLOON BURST. THE PATIENT'S SEX AND AGE ALONG WITH ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762820 UROMAX ULTRA¿ DILATOR, CATHETER, URETERAL EZN M0062251020

    Patients

    Seq Age Sex Outcome Treatment
    1