BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITIP HIGH RESOLUTION CATHETER

    MDR report key: 23209146 · Received October 3, 2025

    Report

    Report Number
    MW5176899
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Report Date
    September 26, 2025
    Manufacturer
    UNISENSOR AG/LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE MEASUREMENT DOES NOT ALWAYS WORK. THE PHYSICIAN WOULD LIKE TO HAVE SOMEONE RECALIBRATE THE CATHETER. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278072 UNITIP HIGH RESOLUTION CATHETER SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX UNISENSOR AG/LABORIE MEDICAL TECHNOLOGIES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown