BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOSCAN ESO Z CATHETER

    MDR report key: 6081502 · Received November 7, 2016

    Report

    Report Number
    3005344223-2016-00003
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 18, 2016
    Manufacturer
    GIVEN GILA (LOS. ANGELES)
    Product Code
    FFX
    PMA / PMN Number
    K091070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (ADDITIONAL ANESTHESIA WAS REQUIRED WHILE THE CATHETER WAS REMOVED FROM THE PATIENT; THERE WAS NO HARM TO THE PATIENT).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN THE PATIENT'S NASAL PASSAGE. THE PATIENT WAS NUMBED AND WELL LUBRICATED BUT THEY COULD STILL NOT GET THE CATHETER OUT. THEY HAD TO PULL THE PROBE OUT OF THE PATIENT'S MOUTH THEN CUT IT IN HALF TO REMOVE IT. THE CATHETER GOT STUCK IN THE PATIENT AFTER THE PROCEDURE WAS COMPLETED. THERE WAS NO BLEEDING. THE PATIENT WAS OFFERED A REFERRAL TO AN ENT BUT THE PATIENT DECLINED. AN EXTRA 1ML OF 4% LIDOCAINE+AFRIN MIXTURE WAS GIVEN TO THE PATIENT TO REMOVE THE CATHETER. THE LAST KNOWN PATIENT STATUS IS THAT THE PATIENT IS CURRENTLY DOING WELL. ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT; SHOULD WE RECEIVE ADDITIONAL INFORMATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732022 MANOSCAN ESO Z CATHETER SYSTEM, GASTROINTESTIONAL MOTILITY (ELECTRICAL) FFX GIVEN GILA (LOS. ANGELES) 3890

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other