BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 671895 · Received February 2, 2006

    Report

    Report Number
    2024168-2006-00038
    Event Type
    Injury
    Date Received
    February 2, 2006
    Date of Event
    December 29, 2005
    Report Date
    January 6, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 5062731

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability