BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT

    MDR report key: 1172064 · Received September 23, 2008

    Report

    Report Number
    2134265-2008-02768
    Event Type
    Injury
    Date Received
    September 23, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MFG DOCUMENTATION FOR THIS PARTICULAR BATCH OF DEVICES THAT WAS USED IN THE PROCEDURE IS NOT POSSIBLE AS THE BATCH NUMBER IS UNK. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED ANTICIPATED PROCEDURAL COMPLICATION DUE TO THE FACT THAT THE COMPLAINT IS ASSOCIATED WITH A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT NONE FGE BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention