BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSURETHRAL CATHETER

    MDR report key: 3963508 · Received June 16, 2014

    Report

    Report Number
    8040412-2014-00133
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 28, 2014
    Product Code
    EZL
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGES: DURING THE FUNCTIONAL TESTING, THE BALLOON WAS INFLATED WITH 3 ML STERILE WATER, AND THE INCIDENT WAS NOTED, AS FOLLOWS: BALLOON DEFLATION AND LOSS OF FLUID AROUND THE VALVE. THE SAMPLE WAS NOT USED IN THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353165 TRANSURETHRAL CATHETER CATHETER EZL 13J14

    Patients

    Seq Age Sex Outcome Treatment
    1