BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON APPLICATOR KIT

    MDR report key: 18788121 · Received February 27, 2024

    Report

    Report Number
    18788121
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 9, 2024
    Report Date
    February 10, 2024
    Manufacturer
    ICAD, INC.
    Product Code
    JAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UPON COMPLETING OF THE IORT (INTRAOPERATIVE RADIATION THERAPY), IT WAS NOTICED BY DOCTOR #1 THAT THE BALLOON FOR THE IORT WAS UNABLE TO DRAIN SALINE. AFTER PULLING OUT THE BALLOON, IT WAS NOTICED THAT THERE WAS A HOLE IN THE BALLOON. DOCTOR #2 NOTIFIED, AND EQUIPMENT WAS SEQUESTERED. AXXENT BALLOON APPLICATOR: LOT: 02308153, REF: AB2060, EXP: 08/22/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628163 BALLOON APPLICATOR KIT SYSTEM, THERAPEUTIC, X-RAY JAD ICAD, INC. 720342 02308153

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female