BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD OPEN ENDED CATHETER, BREAST EXPANDERS

    MDR report key: 483027 · Received September 5, 2003

    Report

    Report Number
    MW1029457
    Event Type
    Malfunction
    Date Received
    September 5, 2003
    Date of Event
    June 27, 2003
    Report Date
    September 5, 2003
    Manufacturer
    *
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT IS A BREAST CA PT. THEY RECEIVED BREAST EXPANDERS AND A BARD ACCESS PORT. THEY WERE GIVEN NO INFO OR "CARD" THAT WOULD TELL THEM ABOUT MRI SAFETY AND CARE OF THE DEVICES. A CALL TO BARD SAID ONLY "TRACKABLE" DEVICES REQUIRE PT INFO CARDS. RPTR ASKS IF FDA SHOULD REQUIRE CARDS TO BE GIVEN TO PTS FOR ALL IMPLANTABLE DEVICES, ESPECIALLY DISCUSSING MRI SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD OPEN ENDED CATHETER, BREAST EXPANDERS ACCESS PORT, BREAST RECONSTRUCTION LJT * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other