BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCOMPASS ANORECTAL MANOMETRY CATHETER

    MDR report key: 17904707 · Received October 10, 2023

    Report

    Report Number
    17904707
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    August 31, 2023
    Report Date
    September 13, 2023
    Manufacturer
    MEDSPIRA, LLC
    Product Code
    KLA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DIFFICULTY TROUBLESHOOTING WITH ANORECTAL MANOMETRY CATHETER X3EA FROM MEDSPIRA. THE COMPANY'S CUSTOMER SERVICE DEPARTMENT TOLD THIS REPORTER TO SEND THEM BACK TO MEDSPIRA FOR CHECKING AND REFUND FOR CATHERTER X3EA. MANUFACTURER RESPONSE FOR ANORECTAL MANOMETRY CATHETER, MCOMPASS (PER SITE REPORTER). REQUESTED FAULTY CATHETERS BE SENT TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331500 MCOMPASS ANORECTAL MANOMETRY CATHETER MONITOR, ESOPHAGEAL MOTILITY, AND TUBE KLA MEDSPIRA, LLC RMD-002-003 L-1103043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown