BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO VIVE INITIAL PLACEMENT PEG KIT

    MDR report key: 510649 · Received February 9, 2004

    Report

    Report Number
    6000048-2004-00004
    Event Type
    Injury
    Date Received
    February 9, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PEJ WAS PLACED IN 11/2002. THERAPEUTIC PROCEDURE AND FOLLOW UP IN DEC 2003 REVEALED AN INFECTED TUBE SITE WITH METHICILLIN RESISTANT STAPH AND YEAST. THE DEVICE WAS REMOVED AND INFECTION RESOLVED WITH NO RESIDUAL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO VIVE INITIAL PLACEMENT PEG KIT TUBES, GASTROINTESTINAL KNT BOSTON SCIENTIFIC CORP. NA 4829308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention