BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD C-MAX CUTTING LOOP

    MDR report key: 3851965 · Received April 14, 2014

    Report

    Report Number
    1018233-2014-00080
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Report Date
    March 20, 2014
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FAS
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227764 BARD C-MAX CUTTING LOOP FAS C.R. BARD, INC. (COVINGTON) NA NGXL1514

    Patients

    Seq Age Sex Outcome Treatment
    1