BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBL COMPONENT, X-RAY CASSETTE TRAY

    MDR report key: 1599919 · Received February 8, 2010

    Report

    Report Number
    2031963-2010-00017
    Event Type
    Injury
    Date Received
    February 8, 2010
    Date of Event
    February 16, 2009
    Report Date
    February 16, 2009
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INFORMATION ON IDENTIFIERS OF PATIENT AT THIS TIME. THE USER GOT A MINOR CUT WHILE USING THE X-RAY CASSETTE HOLDER. THE CUT WAS A LITTLE DEEPER THAN A PAPER CUT WHICH LEAD TO BLEEDING. THERE IS NO ESTABLISHED EXPIRATION DATE FOR THIS DEVICE. SAID DEVICE WAS NOT EVALUATED. THE MALFUNCTION HAS OCCURRED PREVIOUSLY AND WAS INVESTIGATED. THE SAME TYPE OF PRODUCT THAT FAILED WAS EVALUATED IN-HOUSE. EVALUATION SUMMARY: THERE HAVE BEEN TWO INCIDENTS AT THE SAME ACCOUNT. THE FIRST INCIDENT WAS NOT REPORTED; THE SECOND EVENT WAS HOWEVER REPORTED. THE X-RAY CASSETTE TRAY HAS A PULLEY FOR THE USER TO PLACE THE X-RAY UNDER THE SEAT SECTION. THE EDGES OF THE X-RAY CASSETTE TRAY ARE SHARP IF NOT GROUND PROPERLY DURING MANUFACTURING WHICH COULD CAUSE MINOR CUTS TO THE USER. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    PER THE INITIAL REPORT, THE X-RAY CASSETTE TRAY THAT SLIDES UNDER THE OR TABLE HAS VERY SHARP EDGES AND HAS RESULTED IN A MINOR CUT WHICH LED TO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL COMPONENT, X-RAY CASSETTE TRAY FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other