BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVING TRAY, GRAY

    MDR report key: 3240612 · Received July 22, 2013

    Report

    Report Number
    0001831750-2013-06533
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT THE PLASTIC SERVING TRAY WAS DAMAGED AT THE CORNERS. THIS TYPE OF DAMAGE WOULD EXPOSE SHARP EDGES. IT WAS RECOMMENDED THAT DAMAGED SERVING TRAYS BE REPLACED.

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SERVING TRAY WAS BROKEN, RESULTING IN SHARP EDGES BEING EXPOSED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SERVING TRAY WAS BROKEN, RESULTING IN SHARP EDGES BEING EXPOSED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341683 SERVING TRAY, GRAY STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1