BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMT BRIDLE NASAL TUBE RETAINING SYSTEM

    MDR report key: 2509466 · Received March 26, 2012

    Report

    Report Number
    1526012-2011-00003
    Event Type
    Other
    Date Received
    March 26, 2012
    Date of Event
    September 22, 2011
    Report Date
    September 29, 2011
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K030784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL REVIEW OF THE REPORTED INCIDENT FOR THE COMPLAINT INVOLVING A 4-4110 AMT BRIDLE, AMT HAS DECIDED THAT A MEDWATCH FORM 3500A SHOULD HAVE BEEN COMPLETED AND SUBMITTED. THE FOLLOWING INCLUDES THE ANALYSIS OF THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND THE PRODUCT MET DESIGN SPECIFICATIONS. BASED ON A REVIEW OF THE REPORTED INFO, THE DEVICE WAS USED IMPROPERLY AND DANGEROUSLY. IT IS BELIEVED THAT THE DEVICE DID NOT MALFUNCTION DUE TO A MFG DEFECT. THE DEVICE WAS NOT RETURNED TO AMT FOR ANALYSIS. ADDITIONALLY, INFO FROM THIS INCIDENT WAS INCLUDED IN OUR PRODUCT COMPLAINT DATABASE AND MDR TREND REPORTING SYSTEM. AMT WILL CONTINUE TO ANALYZE AND TREND INFO REGARDING THIS DEVICE TO IDENTIFY THE NEED FOR ADD¿L INVESTIGATIONS.

    Description of Event or Problem · 1

    THE USER OF THE BRIDLE OF THE DEVICE (B)(6) DESCRIBED THE EVENT OR PROBLEM AS FOLLOWS: ATTEMPTED PLACEMENT OF NASAL BRIDLE DEVICE. UPON REMOVAL OF THE CATHETER END, THE MAGNET WAS NOTED TO BE MISSING FROM THE END. UPON FURTHER INVESTIGATION WITH HEAD CT¿S AND X-RAYS, IT WAS FOUND THAT THE MAGNET WAS IN THE SUPERIOR ASPECT OF THE RIGHT NASAL CAVITY. ATTEMPTED REMOVAL AT THE BESIDE TIMES TWO WITH RIGID NASAL ENDOSCOPY WAS UNSUCCESSFUL. PLAN FOR OPERATING ROOM REMOVAL. THIS WAS ALREADY REPORTED ON (B)(6) 2011. HOWEVER, I WAS UNABLE TO PRINT THE COPY OF MY SUBMISSION. PT REQUIRED A NASAL BRIDLE DEVICE, THIS WAS PLACED ON (B)(6) 2011. UPON REMOVAL OF THE WHITE CATHETER PORTION OF THE DEVICE, IT WAS NOTED THAT THE MAGNET TIP WAS NO LONGER IN PLACE. UPON X-RAY EVAL, IT WAS FOUND THAT THE MAGNET TIP WAS IN THE SUPERIOR ASPECT OF THE PT¿S RIGHT NASAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMT BRIDLE NASAL TUBE RETAINING SYSTEM NASAL BRIDLE KNT APPLIED MEDICAL TECHNOLOGY, INC. 11070574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention