BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITIP

    MDR report key: 4328965 · Received September 5, 2014

    Report

    Report Number
    4328965
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    July 25, 2014
    Report Date
    September 5, 2014
    Manufacturer
    UNISENSOR USA, INC.
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A HIGH RESOLUTION SYSTEM HAS A BALLOON ATTACHED TO A CATHETER WITH TINY ELASTIC BANDS. UPON REMOVAL OF THE CATHETER THE BALLOON STAYED IN THE PT'S RECTUM. THE PT WAS TOLD TO TRY TO EVACUATE THE BALLOON WHILE TRYING TO MOVE HER BOWELS. NO BALLOON WAS RETURNED. THE PT WAS ENCOURAGED TO WATCH FOR BALLOON OVER THE WEEKEND. PT CHECKED HER STOOL OVER THE WEEKEND AND STILL DID NOT SEE THE BALLOON. SINCE THE PATIENT DID NOT EXPEL THE BALLOON FROM RECTUM, SHE WAS INSTRUCTED TO RETURN TO ENDOSCOPY FOR A FLEXIBLE SIGMOIDOSCOPY TO CHECK FOR THE BALLOON PRESENCE. PT RETURNED AND BALLOON WAS RETRIEVED UNDER DIRECT VISUALIZATION WITHOUT COMPLICATIONS. REPRESENTATIVE WAS PRESENT FOR INITIAL PROCEDURE AND INSTRUCTED THE STAFF TO USE "NON-WAXED DENTAL FLOSS" TO SECURE THE BALLOON IN PLACE FOR FUTURE PROCEDURES. STAFF HAS PERFORMED PROCEDURE SUCCESSFULLY WITHOUT FLOSS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543237 UNITIP GASTROINTESTINAL MOTILITY SYSTEM FFX UNISENSOR USA, INC. UNI-ANO-MO138 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR