BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2539313 · Received April 12, 2012

    Report

    Report Number
    MW5025041
    Event Type
    Injury
    Date Received
    April 12, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CAME TO HAVE A PEG BUTTON PLACED UNDER MAC ANESTHESIA. BUTTON WAS PLACED WITH SOME DIFFICULTY DURING THE PROCEDURE, SOME BLEEDING AT SITE. TWO DAYS LATER, PEG BUTTON DETERMINED BY REP TO BE MALFUNCTIONING, REQUIRING SECOND INCISION FOR SECOND PEG PLACEMENT AND RETURN TO OPERATING ROOM ONE MONTH LATER TO REMOVE MALFUNCTIONING PEG. REASON FOR USE: CHRONIC ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC MICROVASIVE BUTTON REPLACEMENT GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC MOU 563150 14367710

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization