BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MIXING BOWL AND SPATULA

    MDR report key: 2395150 · Received November 23, 2011

    Report

    Report Number
    1822565-2011-02602
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    October 19, 2011
    Report Date
    October 24, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    GAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND INSIDE THE DISPOSABLE MIXING BOWL WHEN THE NURSE OPENED THE STERILE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE MIXING BOWL AND SPATULA GAF ZIMMER INC 61714950

    Patients

    Seq Age Sex Outcome Treatment
    1