BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDE MULTISTAGE DILATION BALLOON CATHETER

    MDR report key: 9156783 · Received October 3, 2019

    Report

    Report Number
    MW5090232
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 13, 2019
    Report Date
    September 15, 2019
    Manufacturer
    MICRO - TECH USA INC.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLEW UP BALLOON TO MAXIMUM PRESSURE FOR PROCEDURE AND BALLOON BURST, USED ANOTHER DEVICE, NO DELAY IN CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947622 RAPIDE MULTISTAGE DILATION BALLOON CATHETER DILATOR, ESOPHAGEAL KNQ MICRO - TECH USA INC. "MM190322204"

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR