BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABORIE AIR-CHARGED CATHETERS

    MDR report key: 19252659 · Received May 3, 2024

    Report

    Report Number
    MW5154584
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Report Date
    May 1, 2024
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    FEN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE IS A MANUFACTURING ISSUE WITH LABORIE AIR CHARGED CATHETERS OF ALL LEVELS FAILURE TO AN EXCESSIVE LEVEL THAT I HAVE NOT SEEN IN 20+ YEARS OF PRACTICE. WE HAVE HAD MORE THAN A DOZEN FAILURES IN THE PAST COUPLE WEEKS OF CATHETERS INSERTED IN THE VAGINA AND RECTUM TO ASSESS VOIDING DYSFUNCTION LOSING CHARGE AND LEAKING SO THAT THEY DON'T RECORD PRESSURE ACCURATELY. THIS REQUIRES THAT THE CATHETER BE REMOVED AND REPLACED DURING THE STUDY CREATING ANXIETY FOR THE PATIENT AND INCREASED DISCOMFORT. THE MACHINE AND CABLES WERE RECENTLY CHECKED BY THE COMPANY AND REPORTEDLY NORMAL. I WONDER IF THEY HAVE A NEW MANUFACTURING PLANT FOR THE CATHETERS BUT THAT IS ONLY A THEORY. I HAVEN'T BEEN ABLE TO GET A STRAIGHT ANSWER AS TO WHY WE ARE SEEING THE REPEATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669488 LABORIE AIR-CHARGED CATHETERS DEVICE, CYSTOMETRIC, HYDRAULIC FEN LABORIE MEDICAL TECHNOLOGIES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown