BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHACOIL

    MDR report key: 260554 · Received January 27, 2000

    Report

    Report Number
    2134479-2000-00002
    Event Type
    Injury
    Date Received
    January 27, 2000
    Date of Event
    January 1, 1999
    Report Date
    January 21, 2000
    Manufacturer
    INTRATHERAPEUTICS, INC.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE REPORT:EUR RADIOLOGY 1999; 9(7): 1418-22. ESOPHACOIL STENT MIGRATION RESULTED IN SURGICAL INTERVENTION. PHYSICIAN CONCLUSION: "INSERTION OF AN ESOPHACOIL HAS GOOD PALLIATIVE EFFECT ON DYSPHAGIA IN PTS WITH MALIGNANT ESOPHAGEAL STRUCTURES WITH FEW COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHACOIL ESOPHAGEAL STENT ESW INTRATHERAPEUTICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention