BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRATOME

    MDR report key: 2941364 · Received January 29, 2013

    Report

    Report Number
    MW5028800
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    November 20, 2012
    Report Date
    January 21, 2013
    Product Code
    FDR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HYDRATOME USED IN ERCP PROCEDURE WOULD NOT BOW OUT. MANUFACTURE REP MADE AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39746 HYDRATOME BOSTON SCIENTIFIC ENDOSCOPE FDR 120815

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention