BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 494860 · Received November 7, 2003

    Report

    Report Number
    2024168-2003-00379
    Event Type
    Malfunction
    Date Received
    November 7, 2003
    Date of Event
    September 29, 2003
    Report Date
    October 8, 2003
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LABELING OF THE OUTER PACKAGE (THE CHIPBOARD) OF THE MULTI-LINK ZETA WAS DIFFERENT FROM THAT OF THE INNER PACKAGE (THE POUCH). THE CHIPBOARD INDICATED THAT THE PART NUMBER OF THE ZETA WAS 1009839-13 AND THE LOT NUMBER WAS 3051531 WHILE THE POUCH INDICATED THAT THE PART NUMBER WAS 1009838-33 AND THE LOT NUMBER WAS 3051634. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX ZETA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 3051531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN