BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBL COMPONENT, 5TH WHEEL TABLE SEAT SECTION ON

    MDR report key: 1621927 · Received February 5, 2010

    Report

    Report Number
    2031963-2009-00057
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    January 16, 2008
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B)(6)2006 TO (B)(6)2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED UNDER EXEMPTION #(B)(4). THERE ARE 7 EVENT(S) ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE FQO.

    Description of Event or Problem · 1

    LEAK. VERTIER TABLE IS LEAKING HYDRAULIC (FLUID WILL IMPACT FUNCTION - MALFUNCTION LEADING TO SERIOUS INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL COMPONENT, 5TH WHEEL TABLE SEAT SECTION ON FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA