BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOSITE RTS

    MDR report key: 513840 · Received January 29, 2004

    Report

    Report Number
    MW1031249
    Event Type
    Injury
    Date Received
    January 29, 2004
    Date of Event
    December 22, 2003
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS SEEN BY RADIATION ONCOLOGIST IN 2003 FOR 6 MONTH FOLLOW-UP POST BRACHYTHERAPY TREATMENT. PT PRESENTED WITH A "CRATER" 4 CM X 4 CM SUBCUTANEOUS THAT WILL BE REPAIRED BY PLASTIC SURGEON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOSITE RTS BRACHY (RADIATION) THERAPY BALLOON KXK PROXIMA THERAPEUTICS, INC. NOT IN CHART *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention RADIATION THERAPY 2 X DAY 2003 - 2003 FOR TOTAL OF| 10 TREATMENTS.