BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETER

    MDR report key: 8394217 · Received March 6, 2019

    Report

    Report Number
    8394217
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 7, 2019
    Report Date
    February 12, 2019
    Manufacturer
    MEDSPIRA LLC
    Product Code
    HCC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING BIOFEEDBACK SESSION, BALLOON PART OF THE BIOFEEDBACK CATHETER BROKE WHILE IN THE PATIENT. MANUFACTURER RESPONSE FOR ANORECTAL MANOMETRY CATHETER, MCOMPASS BIOFEEDBACK 2 CHANNEL ANORECTAL MANOMETRY CATHETER (PER SITE REPORTER). THIS IS THE FIFTH CASE OF THIS TYPE FOR THIS PARTICULAR DEVICE EXPERIENCED BY (B)(6) HOSPITALS OVER THE PAST SIX WEEKS. COMPANY HAS BEEN MADE AWARE AND HAS MADE ARRANGEMENTS TO REPLACE ALL EXISTING STOCK WITH THIS ADDITIONAL LOT NUMBER (SEE PREVIOUS REPORT). UNAWARE IF OTHER FOLLOW UP HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189689 MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETER DEVICE, BIOFEEDBACK HCC MEDSPIRA LLC RMD-002-004 19011401

    Patients

    Seq Age Sex Outcome Treatment
    1 13140 DA Other