BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GVL BLADES

    MDR report key: 3042456 · Received February 6, 2013

    Report

    Report Number
    9615393-2013-00031
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THAT VERATHON WAS NOTIFIED OF ALL ISSUES NOTED. HOWEVER, WE BECAME AWARE OF THIS ISSUE BY REVIEWING THE MAUDE DATABASE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE FDA THAT AFTER FDA MEDWATCH EMAILED IN 2012, ABOUT VERATHON GVL BLADES, THEIR ORGANIZATION REVIEWED ALL BLADES, AND DISCOVERED THAT SOME ARE GROOVED AND CRACKED. THE BLADES WERE OUTSIDE OF THE RECALL SERIAL NUMBER RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51479 GVL BLADES NONE CCW VERATHON MEDICAL (CANADA) ULC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1