BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCOMPASS MANOMETRIC BIOFEEDBACK SYSTEM

    MDR report key: 8683962 · Received June 7, 2019

    Report

    Report Number
    MW5087234
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 5, 2019
    Manufacturer
    MEDSPIRA LLC
    Product Code
    HCC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDSPIRA BIOFEEDBACK DEVICE WAS INSERTED INTO RECTUM TO MEASURE SENSITIVITY AND PRESSURE. BALLOON ON THE END OF CATHETER WAS GRADUALLY INFLATED DURING PROCEDURE AND EVENTUALLY POPPED INSIDE OF ME. DUE TO MY HYPOSENSITIVITY, NO PAIN WAS FELT WHEN THIS HAPPENED OR AFTERWARDS AND PROCEDURE WAS TERMINATED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470803 MCOMPASS MANOMETRIC BIOFEEDBACK SYSTEM DEVICE, BIOFEEDBACK HCC MEDSPIRA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR