BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 6FR 100% SILICONE FOLEY CATHETER 1.5CC

    MDR report key: 1880950 · Received October 5, 2010

    Report

    Report Number
    8040412-2010-00064
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MFR, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: POST SURGERY WHEN THE DRAPE WAS REMOVED, IT WAS NOTED THAT THE CATHETER HAD FALLEN OUT AND WAS ON THE FLOOR. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH 6FR 100% SILICONE FOLEY CATHETER 1.5CC FOLEY CATHETER EZL TELEFLEX MEDICAL NA 10BE19

    Patients

    Seq Age Sex Outcome Treatment
    1