BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 12842924 · Received November 19, 2021

    Report

    Report Number
    3005580113-2021-00140
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 18, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002353753
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS A CORRECTION TO INITIAL MDR # 3005580113-2021-00138 FOR WILLIAM COOK (B)(4) FEI# (B)(4) WAS INADVERTENTLY SENT BY THE COOK MEDICAL LLC FEI# (B)(4). PLEASE REMOVE MDR# 3005580113-2021-00138 AS THIS INFORMATION HAS ALREADY BEEN REPORTED UNDER MDR# 3002808486-2021-01896.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743810 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH WILLIAM COOK EUROPE G35375 E4089517 10827002353753

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention