BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT BRIDLE

    MDR report key: 8164748 · Received December 14, 2018

    Report

    Report Number
    1526012-2018-00009
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    October 1, 2018
    Report Date
    December 7, 2018
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K142971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESPONSE TO USER FACILITY # 4100070000-2018-8093. WE HAVE ASSIGNED (B)(4) TO THIS REPORT. BASED ON THE REPORTED INFORMATION, THERE WAS NO DEATH NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR A SERIOUS INJURY THAT IS LIFE-THREATENING, AS DEFINED BY THE FDA. HOWEVER, INTERVENTION WAS REQUIRED TO TRY TO REMOVE THE MAGNET FROM THE PATIENT'S NASAL CAVITY. THERE WAS NO RECORD OF HARM TO THE PATIENT PROVIDED AND NO PATIENT COMPLICATIONS RESULTED FROM THE ATTEMPTED REMOVAL OF THE MAGNET. THE REMAINING DEVICE COMPONENTS WERE DISCARDED AFTER USE AND WAS NOT AVAILABLE FOR RETURN, SO THE DEVICE COULD NOT BE EVALUATED AND DEVICE FAILURE COULD NOT BE CONFIRMED. A DHR REVIEW WAS COMPLETED AND BECAUSE NO ANOMALIES WERE OBSERVED THE INCIDENT IS NOT BELIEVED TO HAVE RESULTED FROM A MANUFACTURING DEFECT. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ITS ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 1

    AT THE END OF PROCEDURE, THE RESIDENT ATTEMPTED TO PLACE BRIDLE AND WAS HAVING DIFFICULTY. SECOND RESIDENT ATTEMPTED TO HELP PLACE BRIDLE. MAGNET FROM BRIDLE WAS LOST IN PATIENT. ENT WAS CONSULTED. ENT PA WAS UNABLE TO VISUALIZE FOREIGN BODY. X-RAY WAS TAKEN. FOREIGN BODY WAS SEEN ON X-RAY OF PATIENT'S HEAD. ENT ATTENDING CAME TO OPERATING ROOM FOR EMERGENT FOREIGN BODY RETRIEVAL. ATTENDING WAS UNSUCCESSFUL. BOTH ATTENDINGS AGREED PATIENT WAS SAFE TO BE EXTUBATED. ATTENDINGS AGREED TO SCHEDULE A CT SCAN FOR PATIENT AND NOTIFY NURSING STAFF TO MONITOR PATIENT'S EXPECTANT FOR FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005961 AMT BRIDLE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. 4-41 171222-324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention