BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORGRIP TUBE RETENTION SYSTEM

    MDR report key: 8711633 · Received June 19, 2019

    Report

    Report Number
    8711633
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 25, 2019
    Report Date
    June 10, 2019
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT TO MRI SCANNER IN THE RADIOLOGY/IMAGING DEPARTMENT TO HAVE A BRAIN SCAN. THE TECHNOLOGIST REPORTED THAT THE MAGNETIC WAND DID NOT INDICATE MAGNETISM NOTED NEAR THE PATIENT'S HEAD. THERE WERE ALSO NO VISIBLE SIGNS OF METAL DETECTED ON THE INSPECTION. IN THE MRI, THE STRING WITH THE MAGNET ATTACHED ON THE END PULLED SUGGESTING METAL PRESENT. UPON CLOSER INSPECTION OF THE CLOTH TAPE OF BRIDLE (NASOGASTRIC TUBE RETENTION SYSTEM), IT REVEALED THAT THE MAGNET TIP WAS STILL ON THE TAPE IMBEDDED IN CLOTH. THE SMALL MAGNET WAS REMOVED AND THE MRI WENT FORTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507784 CORGRIP TUBE RETENTION SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. 25-018 79122

    Patients

    Seq Age Sex Outcome Treatment
    1 8395 DA