BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOSCAN

    MDR report key: 11879378 · Received May 25, 2021

    Report

    Report Number
    3007662958-2021-00002
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 25, 2021
    Manufacturer
    GIVEN IMAGING VIETNAM CO LTD
    Product Code
    FFX
    UDI-DI
    04260167482446
    PMA / PMN Number
    K151086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CATHETER WAS STUCK IN THE PATIENT'S NOSE. SEDATION WAS REQUIRED TO REMOVE THE DEVICE. THE PATIENT WAS GIVEN MUSCLE RELAXERS FOR PAIN. THEY FOLLOWED UP WITH THE PATIENT THE NEXT DAY AND AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777039 MANOSCAN SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX GIVEN IMAGING VIETNAM CO LTD 3890 04260167482446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention