BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTURA

    MDR report key: 2143027 · Received June 22, 2011

    Report

    Report Number
    2143027
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    SENORX INC.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD RADIATION BALLOON INSERTED ON (B)(6) 2011 - LEFT BREAST AS OUTPATIENT - POST LUMPECTOMY DONE ON (B)(6) 2011. CATHETER NOTED TO BE DEFECTIVE - LEAKING. CATHETER REMOVED AND REPLACEMENT DEVICE INSERTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTURA MULTILUMEN RADIATION BALLOON CATHETER JAQ SENORX INC. CONTURAMLB 4-5 CM M11020204

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention