BEUDAMED
    FDA Adverse Event Other Summary report: N

    TBL COMPONENT, X-RAY CASSETTE TRAY

    MDR report key: 1613201 · Received February 8, 2010

    Report

    Report Number
    2031963-2010-00032
    Event Type
    Other
    Date Received
    February 8, 2010
    Date of Event
    June 27, 2008
    Report Date
    July 10, 2008
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT. THEREFORE, THIS INFO IS NOT APPLICABLE. THERE IS NO ESTABLISHED EXPIRATION DATE FOR THIS DEVICE. THE SURGICAL TABLE IS NOT AN IMPLANTABLE DEVICE. THE SURGICAL TABLE IS NOT AN EXPLANTABLE DEVICE. THE X-RAY CASSETTE TRAY DOES NOT HAVE A SERIAL NUMBER ATTACHED. THEREFORE, A DATE OF MANUFACTURE CANNOT BE DETERMINED. EVAL SUMMARY: IF THE SURGICAL TABLE'S X-RAY CASSETTE TRAY WERE DEEMED TOO SHARP, IT COULD POSSIBLY CAUSE A CUT TO THE USER. CORRECTIVE ACTION WAS TAKEN, AND THE CUSTOMER WAS PROVIDED WITH EDGES LESS SHARP. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER, AN X-RAY CASSETTE TRAY WAS FOUND WHERE THERE WERE NO GUARDS ON THE EDGES. THERE WAS NO REPORT OF PT INVOLVEMENT, AND THERE ARE NO ADVERSE CONSEQUENCES AS A RESULT THEREOF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL COMPONENT, X-RAY CASSETTE TRAY FQO STRYKER COMMUNICATIONS NA NOT SERIALIZED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA