BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORONARY DRUG-ELUTING STENT

    MDR report key: 18408988 · Received December 27, 2023

    Report

    Report Number
    MW5149601
    Event Type
    Injury
    Date Received
    December 27, 2023
    Report Date
    December 11, 2023
    Manufacturer
    ELIXIR MEDICAL CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    POOR QUALITY, THERE WERE 2 CASES OF STENT THROMBOSIS BACK TO BACK IN TWO DAYS BECAUSE OF WHICH WE APPROACHED YOU TO TAKE BACK THE PRODUCTS AS THE DOCTORS AND HOSPITALS HAVE DENIED USING IT FURTHER. REF REPORT: MW5149602.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361062 CORONARY DRUG-ELUTING STENT CORONARY DRUG-ELUTING STENT NIQ ELIXIR MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown