BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSTON CORONARY CANNULA BALLOON

    MDR report key: 2752359 · Received June 24, 2008

    Report

    Report Number
    2752359
    Event Type
    Injury
    Date Received
    June 24, 2008
    Date of Event
    May 8, 2008
    Report Date
    June 22, 2008
    Manufacturer
    MAQUET INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT MALFUNCTION UPON INSPECTION BEFORE AND IMMEDIATELY AFTER OPENING PACKAGE. OBSERVED ALL BALLOONS HAD RUPTURED OR HAD A CRACK. ALL PRODUCTS WITH THE SAME LOT NUMBER WER REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSTON CORONARY CANNULA BALLOON CORONARY PERFUSION CANNULA DWF MAQUET INC. 238942

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention