BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2637552 · Received June 11, 2012

    Report

    Report Number
    2637552
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 7, 2012
    Report Date
    June 6, 2012
    Manufacturer
    E. BENSON HOOD LABORATORIES, INC.
    Product Code
    FWN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    EXPLANT OF BRONCHIAL STENT. PATIENT WHO HAS HISTORY OF END-STAGE LUNG DISEASE DUE TO PULMONARY FIBROSIS WHO HAS UNDERGONE BILATERAL SEQUENTIAL PULMONARY TRANSPLANTATION APPROXIMATELY 6 MONTHS AGO. SHE HAS HAD POSTOPERATIVE GASTROESOPHAGEAL REFLUX AND HAS HAD INFLAMMATORY STENOSIS OF THE BRONCHUS INTERMEDIUS ULTIMATELY REQUIRING PLACEMENT OF A SILASTIC STENT, 8 X 13 MILLIMETERS. SHE HAD RECENT SURVEILLANCE BRONCHOSCOPY, WHICH INDICATED POSSIBLE MIGRATION OR DISTORTION OF THE STENT AND REPEAT AIRWAY EVALUATION IS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STENT, BRONCHIAL FWN E. BENSON HOOD LABORATORIES, INC. * 11021

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR