BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM ANGLED TOMCAT CUTTER, FORMULA (5BX)

    MDR report key: 1861246 · Received October 1, 2010

    Report

    Report Number
    2648666-2010-00418
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SOON AS THE UNIT WAS PUT INTO THE KNEE, IT BEGAN TO FLAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM ANGLED TOMCAT CUTTER, FORMULA (5BX) CUTTER HRX STRYKER ENDOSCOPY PUERTO RICO 10203CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK