BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1021615 · Received February 25, 2008

    Report

    Report Number
    1021615
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD MULTIPLE ESOPHAGEAL STENTS PLACED. PATIENT ADMITTED APPROXIMATELY 7 MONTHS LATER WITH DYSPHAGIA. MD DID EGD AND FOUND LARGE PIECES OF A "RUBBERY LIKE" SUBSTANCE CLOGGING LOWER ESOPHAGUS. SUBSTANCE REMOVED AND SENT TO PATHOLOGY. SUBSTANCE APPEARS TO BE THE COVERING FROM THE STENT THAT PREVENTS THE TUMOR FROM GROWING INTO THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STENT, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORP. REF 1373 & 5662 .038.260 9671994

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR