BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOSCAN

    MDR report key: 14575091 · Received June 2, 2022

    Report

    Report Number
    3005344223-2022-00001
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 2, 2022
    Manufacturer
    GIVEN IMAGING LOS ANGELES LLC
    Product Code
    FFX
    UDI-DI
    04260167482446
    PMA / PMN Number
    K151086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THEY COULD NOT REMOVE PROBE FROM THE PATIENT'S NOSE. MULTIPLE ATTEMPTS BY GASTROENTEROLOGIST TO REMOVE PROBE AFTER (B)(6) SPRAY AND REPOSITIONING OF PROBE AND PATIENT. THE PATIENT'S COMPLAINTS WERE SORE NOSE AND THROAT. SENT TO RADIOLOGY WHERE ATTEMPTS WERE MADE UNDER FLUOROSCOPY; ALSO THE RADIOLOGIST TRIED PLACING A REMOVABLE DEVICE OVER THE PROBE TO ALLOW IT TO CREATE A BARRIER BETWEEN THE NOSTRIL AND THE PROBE ITSELF WITH NO SUCCESS. X-RAYS WERE NEEDED AND FINALLY THE PATIENT NEEDED TO BE PLACED UNDER SEDATION FOR EGD. THE PROBE WAS ABLE TO BE REMOVED. THE PATIENT WAS CONTACTED THE NEXT DAY AND IS NOW DOING WELL, AND THE SORE THROAT WAS SUBSIDING AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153920 MANOSCAN SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX GIVEN IMAGING LOS ANGELES LLC 3890 04260167482446

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention