BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-DOC AIR-CHARGED SINGLE SENSOR COUDE CATHETER

    MDR report key: 8695411 · Received June 13, 2019

    Report

    Report Number
    9681424-2019-00002
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 13, 2019
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CANADA ULC
    Product Code
    FEN
    UDI-DI
    00627825001045
    PMA / PMN Number
    K951805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT DID NOT RESULT IN A SERIOUS INJURY OF THE PATIENT OR REQUIRE MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED TO THE FDA BASED ON A REVIEW OF THE RISK DOCUMENTATION FOR THE DEVICE WHICH IDENTIFIED THAT, WERE THIS MALFUNCTION TO OCCUR AGAIN, THERE IS THE POSSIBILITY THAT MEDICAL INTERVENTION MIGHT BE NECESSARY TO PREVENT SERIOUS INJURY. LABORIE IS STILL AWAITING ADDITIONAL INFORMATION FROM THE REPORTER RELATED TO THIS EVENT, AS WELL AS THE SUBJECT DEVICE TO BE RETURNED, IN ORDER FOR A MORE THOROUGH INVESTIGATION TO BE PERFORMED. ONCE LABORIE HAS OBTAINED FURTHER DETAILS ON THIS EVENT AND HAS BEEN ABLE TO REVIEW POTENTIAL ROOT CAUSES, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    A LABORIE URETHRAL CATHETER WAS USED IN A PATIENT IN FRANCE AS PART OF A URODYNAMICS STUDY. A METAL FILAMENT IN THE CATHETER WAS PROTRUDING AND RESULTED IN A LESION OF THE PATIENT'S URETHRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491724 T-DOC AIR-CHARGED SINGLE SENSOR COUDE CATHETER CATHETER FOR USE WITH URODYNAMIC SYSTEMS FEN LABORIE MEDICAL TECHNOLOGIES CANADA ULC CAT878 181576 00627825001045

    Patients

    Seq Age Sex Outcome Treatment
    1