BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDOC AIR-CHARGED CATHETER

    MDR report key: 8427288 · Received March 17, 2019

    Report

    Report Number
    9681424-2019-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2019
    Date of Event
    February 11, 2019
    Report Date
    March 12, 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 Location
    SZ
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    A LABORIE CATHETER WHICH WAS USED IN A MALE PATIENT IN (B)(6) AS PART OF A URODYNAMICS STUDY HAD A STEEL WIRE PROTRUDING FROM THE CATHETER. THE PHYSICIAN EITHER DID NOT NOTICE THE DEFECT PRIOR TO INSERTING THE CATHETER INTO THE PATIENT, OR THE DEFECT OCCURRED AFTER INSERTION INTO THE PATIENT - WE ARE UNABLE TO TELL BASED ON THE INFORMATION PROVIDED - WHICH RESULTED IN THE PATIENT'S URETHRA RECEIVING MINOR SCRATCHES UPON REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS PRODUCT MALFUNCTION; THE PATIENT WAS RELEASED AND DID NOT REQUIRE ADDITIONAL FOLLOW-UP OR TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220574 TDOC AIR-CHARGED CATHETER CATHETER FOR USE WITH URODYNAMIC SYSTEM FEN LABORIE MEDICAL TECHNOLOGIES CANADA ULC CAT 880 180716 00627825001045

    Patients

    Seq Age Sex Outcome Treatment
    1