BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 11300605 · Received February 9, 2021

    Report

    Report Number
    3005580113-2021-00017
    Event Type
    Injury
    Date Received
    February 9, 2021
    Report Date
    February 9, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED "THE STENT RESTENOSIS AND REQUIRED SUBSEQUENT RECANALIZATION." AN ADDITIONAL PROCEDURE REQUIRED TO SUBSEQUENTLY PLACE ANOTHER STENT INSIDE THE OCCLUDED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196602 UNKNOWN UNKNOWN NIU COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention