BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT ESOPHAGUS TTS (CCC)

    MDR report key: 12305651 · Received August 11, 2021

    Report

    Report Number
    3008146331-2021-00002
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 28, 2021
    Manufacturer
    M.I.TECH CO.,LTD.
    Product Code
    ESW
    UDI-DI
    08806367088482
    PMA / PMN Number
    K200860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    SALES REP. (B)(6) CALLED, AND REPORTED AN ISSUE, WHERE THE INNER TUBE OF THE DELIVERY SYSTEM BECAME LODGED IN A GIF-1TQ160 WHEN THE OUTER SHEATH WAS REMOVED POST STENT DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203231 HANAROSTENT ESOPHAGUS TTS (CCC) PROSTHESIS, ESOPHAGEAL ESW M.I.TECH CO.,LTD. ECBA-20-100-180 20100290 08806367088482

    Patients

    Seq Age Sex Outcome Treatment
    1