BEUDAMED
    FDA Adverse Event Death Summary report: N

    MONTGOMERY TUBE

    MDR report key: 9933737 · Received April 7, 2020

    Report

    Report Number
    MW5094059
    Event Type
    Death
    Date Received
    April 7, 2020
    Date of Event
    October 4, 2019
    Report Date
    March 4, 2020
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6) REPORTED BY DR (B)(6), ANESTHETIST TO BOSTON MEDICAL PRODUCTS INC. (B)(4) DISTRIBUTOR, (B)(4) TO BOSTON MEDICAL PRODUCTS INC. ON (B)(6) 2020 PATIENT REQUIRED ESOPHAGEAL STENT PLACEMENT RELATED TO STENT PLACEMENT. MONTGOMERY TUBE IN-SITU. BLEEDING AND MORTALITY DIRECTLY AND TEMPORALLY RELATED TO STENT PLACEMENT. MONTGOMERY TUBE PRESENCE WAS PURELY INCIDENTAL AND WAS NOT RELATED TO DEATH IN ANY WAY. RELATED TO BMPL BY (B)(4), MONTGOMERY TUBE THAT WAS IN-SITU WAS: REF. 721310; LOT NO. 091090.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396022 MONTGOMERY TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR BOSTON MEDICAL PRODUCTS, INC. 091090

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death