BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FOLEY CATHETER 100%SILICONE 2WAY 5CC 18F

    MDR report key: 1934345 · Received November 24, 2010

    Report

    Report Number
    8040412-2010-00111
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR IF IT WAS THE PT OR THE NURSE WHO ORIGINALLY REPORTED THIS COMPLAINT. PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BALLOON LEAKED ONE HOUR AFTER CATHETER INSERTION. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH FOLEY CATHETER 100%SILICONE 2WAY 5CC 18F FOLEY CATHETER EZL TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1