BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA¿

    MDR report key: 7464243 · Received April 26, 2018

    Report

    Report Number
    3005099803-2018-01396
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Report Date
    March 31, 2018
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 2 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012012, BOTH DEVICES WERE RETURNED. BOTH EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER E2012012 FOR PRODUCT CODE EZN. THIS REPORT COVERS 2 REPORTED EVENTS OF BALLOON PINHOLES. BOTH PATIENTS WERE FEMALE. BOTH PATIENTS' AGES WERE (B)(6) YEARS. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308331 UROMAX ULTRA¿ DILATOR, CATHETER, URETERAL EZN M0062251010

    Patients

    Seq Age Sex Outcome Treatment
    1