BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN DUMON SILICONE STENT

    MDR report key: 9244400 · Received October 28, 2019

    Report

    Report Number
    9244400
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 9, 2019
    Manufacturer
    LYMOL MEDICAL CORPORATION
    Product Code
    NWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON PLACED SILICONE STENT (12X30); AFTER MANIPULATION, THE STENT TORE. SURGEON HAD TO REMOVE STENT. WE ONLY HAD ONE OF THE IMPLANTS IN STOCK. SURGEON HAD TO REPLACE STENT WITH A DIFFERENT SIZE (NOT AS IDEAL AS INITIAL STENT BEING PLACED) (10X30). SURGEON BELIEVES THIS COMPROMISES PATIENT CARE, AS THE IDEAL STENT COULDN'T BE PLACED. PATIENT MAY NEED TO COME BACK TO RECEIVE PROPER SIZE IMPLANT. RIGID BRONCHOSCOPY WITH SILICONE STENT PLACEMENT. BRYAN DUMON SILICONE STENT 12X30(BD0398) LOT: 3831591 WAS IMPLANTED AND WHILE HE WAS REPOSITIONING IT (WITH A STENT GRASPER), THE STENT TORE. SO, HE HAD TO PLACE A 10X30(BD0374) LOT: 3831589 STENT BECAUSE WE DIDN'T HAVE ANOTHER 12X30 STENT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038012 BRYAN DUMON SILICONE STENT BRONCHOSCOPE (FLEXIBLE OR RIGID) NWA LYMOL MEDICAL CORPORATION 3831591

    Patients

    Seq Age Sex Outcome Treatment
    1 8760 DA