BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL RADIUS RESECTOR

    MDR report key: 1840175 · Received September 14, 2010

    Report

    Report Number
    MW5017450
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONMED LINVATEC FULL RADIUS RESECTOR, LEFT METAL SHAVINGS IN THE PATIENTS OPERATIVE KNEE-(B)(4) LOT 101776. THE REGIONAL MANAGER WAS CALLED. (B)(4) STATED HE HAD SEEN THIS HAPPEN WITH OTHER COMPANIES' SHAVERS AS WELL. DATES OF USE: (B)(6)2010 - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: ARTHROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL RADIUS RESECTOR FULL RADIUS RESECTOR HWE CONMED LINVATEC 101776

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other