BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1569903 · Received December 30, 2009

    Report

    Report Number
    1569903
    Event Type
    Malfunction
    Date Received
    December 30, 2009
    Date of Event
    May 20, 2009
    Report Date
    June 4, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PEG AND FAILED PEJ INSERTION WITH USE OF RESOLUTION CLIP ON (B) (6) 2009. APPROX 2 WEEKS LATER, ABDOMINAL CT REFLECTED METALLIC FOREIGN BODY. PT LATER HAD SURGICAL REMOVAL OF RESOLUTION CLIP FROM JEJUNUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC RESOLUTION CLIP FZP BOSTON SCIENTIFIC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other