BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 100% SIL TIEMANN 2WAY 5CC

    MDR report key: 3905040 · Received May 27, 2014

    Report

    Report Number
    8040412-2014-00115
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Product Code
    EZL
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: IT WAS REPORTED THAT "THE CATHETER WAS USED 4 WEEKS; THE BALLOON EMPTIED ITSELF SPONTANEOUSLY. BY INSPECTION OF THE CATHETER, THERE WAS A LEAK BELOW THE BALLOON." NO PATIENT INJURY REPORTED. PATIENT CURRENT CONDITION IS REPORTED, AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311965 RUSCH 100% SIL TIEMANN 2WAY 5CC FOLEY CATHETER EZL 13CT49

    Patients

    Seq Age Sex Outcome Treatment
    1