BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDO CUTTER CATHETER

    MDR report key: 1043131 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33520
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDO CUTTER CATHETER GUIDE CATHETER LWS EXTERNAL MANUFACTURER 7516 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE H217/715026 WAS IMPLANTED 12-FEB-2008| THE DEVICE 4549/161884 WAS IMPLANTED 12-FEB-2008| THE DEVICE 4470/574083 WAS IMPLANTED 12-FEB-2008| THE DEVICE 0185/190641 WAS IMPLANTED 12-FEB-2008| THE DEVICE 4470/574722 WAS IMPLANTED 12-FEB-2008