BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 2393058 · Received December 21, 2011

    Report

    Report Number
    1036445-2011-00272
    Event Type
    Injury
    Date Received
    December 21, 2011
    Date of Event
    October 26, 2011
    Report Date
    December 21, 2011
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE HYSTEROSALPINGOGRAPHY PROCEDURE, RADIOLOGIST MADE MULTIPLE ATTEMPTS IN ORDER TO DEFLATE A FOLEY BALLOON CATHETER AND TO REMOVE IT FROM PT'S FALLOPIAN TUBES. SINCE THE BALLOON COULD NOT BE DEFLATED, DOCTOR CUT THE CATHETER ACROSS AND REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL WELL LEAD MEDICAL CO. LTD 2 WAY 3-5CC 8 FR 1105010769

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention