BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON APPLICATOR KIT 5-6 SPHERICAL

    MDR report key: 1030956 · Received April 16, 2008

    Report

    Report Number
    3005594788-2008-00004
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 16, 2008
    Manufacturer
    XOFT, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K050843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BALLOON RUPTURE DURING BRACHYTHERAPY OF THE BREAST IS AN ANTICIPATED EVENT. THE DEVICE WAS NOT RETURNED TO THE SUPPLIER AND WITH OUT THE ACTUAL DEVICE AN EVAL CANNOT BE MADE. IF THE EVENT THE DEVICE IS RETURNED AND AN INVESTIGATION IS CONDUCTED A CORRECTED REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A 3-4 CM SPHERICAL BALLOON RUPTURED POST IMPLANTATION. THE PT HAD RECEIVED 9 OUT OF 10 TREATMENTS. THE BALLOON WAS NOT REPLACED AND THE 10TH TREATMENT WAS NOT ADMINISTERED. INCIDENT DID NOT RESULT IN A PT INJURY. BALLOON RUPTURE IS AN ANTICIPATED ADVERSE EVENT PER THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON APPLICATOR KIT 5-6 SPHERICAL BALLOON APPLICATOR JAQ XOFT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention