BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COIL EMBL 2CM 2MM AZUR CX

    MDR report key: 17247082 · Received June 30, 2023

    Report

    Report Number
    MW5119050
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    January 26, 2020
    Report Date
    June 29, 2023
    Manufacturer
    TERUMO MEDICAL CANADA, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY MOM, (B)(6) WAS A PATIENT AT (B)(6) BEGINNING (B)(6) 2020 WHEN RECALLED PRODUCTS WERE IMPLANTED. HERE'S THE PRODUCT INFO: HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFRES/RES.CFM?ID=178674. THE FOLLOWING PRODUCTS ARE ON THE RECALL LIST AND WERE IMPLANTED: MODEL NUMBER:45-780308 MODEL NUMBER:45-780204 MODEL NUMBER:45-780202. VARIOUS IMPLANTS AFTER A MOTOR VEHICLE ACCIDENT. PLEASE INQUIRE FOR LIST OF OTHER IMPLANTS, EXPLANTS AND THOSE LOT NUMBERS. REFERENCE REPORTS: MW5119048, MW5119049.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040592 COIL EMBL 2CM 2MM AZUR CX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD TERUMO MEDICAL CANADA, INC. 45-780202 1910315Z8

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female