BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100% SILICONE 2WAY 30CC FOLEY CATHETER 18 FR

    MDR report key: 1880861 · Received October 1, 2010

    Report

    Report Number
    8040412-2010-00069
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 13, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RETURNED TO MFR AT TIME OF THIS REPORT. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BALLOON DEFLATED DURING TREATMENT. NO PT INJURY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 100% SILICONE 2WAY 30CC FOLEY CATHETER 18 FR 2 WAY FOLEY CATHETER KOD TELEFLEX MEDICAL NA 09EE22

    Patients

    Seq Age Sex Outcome Treatment
    1