BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SOFT SIMPLASTIC 3-WAY CATHETER

    MDR report key: 2043460 · Received February 25, 2011

    Report

    Report Number
    8040412-2011-00020
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT REPORTED AS: FOLLOWING BLADDER SURGERY, THE BALLOON DEFLATED AND FELL OUT OF THE PT APPROX SIX HOURS AFTER INSERTION. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SOFT SIMPLASTIC 3-WAY CATHETER UROLOGICAL CATHETER KOD TELEFLEX MEDICAL NA 101E39

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK