BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXENT E BX BALLOON APPLICATOR KIT

    MDR report key: 7095785 · Received December 6, 2017

    Report

    Report Number
    MW5073811
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 17, 2017
    Report Date
    November 28, 2017
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD, INC.
    Product Code
    JAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 3-4 CM BALLOON APPLICATOR KIT FAILED INTRAOPERATIVELY. THE VALVE WOULD NOT ALLOW THE SURGEON TO INFLATE OR DEFLATE THE BALLOON. MALFUNCTION CAUSED A DELAY IN THE CASE. NO HARM REACHED THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865915 AXXENT E BX BALLOON APPLICATOR KIT AXXENT E BX BALLOON APPLICATOR KIT JAD XOFT, A SUBSIDIARY OF ICAD, INC. AB2060 01707051

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention