BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 3145521 · Received May 23, 2013

    Report

    Report Number
    3005594788-2013-00003
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 23, 2013
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD INC.
    Product Code
    JAD
    PMA / PMN Number
    K090914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE LIKELY DUE TO A COMPONENT OR MFG DEFECT; CORRECTIVE AND PREVENTATIVE ACTION IS IN PROGRESS.

    Description of Event or Problem · 1

    PHYSICIAN HAD DIFFICULTY DRAWING THE SALINE BACK OUT OF THE BALLOON APPLICATOR TO THE POINT WHERE INTERVENTION WAS REQUIRED TO REMOVE THE BALLOON WHILE STILL FULL OF SALINE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228069 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR JAD XOFT, A SUBSIDIARY OF ICAD INC. 720342 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention