BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCGEE

    MDR report key: 408480 · Received July 22, 2002

    Report

    Report Number
    1037007-2002-00010
    Event Type
    Other
    Date Received
    July 22, 2002
    Date of Event
    July 10, 2002
    Report Date
    July 10, 2002
    Manufacturer
    GYRUS ENT
    Product Code
    ETB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE AFFECTED PRODUCT IS NORMALLY DELIVERED IN A PROTECTIVE MOLD OF BLUE SILICONE. THIS BLUE MOLD IS SEALED INSIDE A FORM-FILL-SEAL MYLAR/TYVEK POUCH AND PLACED INSIDE A CARDBOARD OUTER CARTON, WHICH IS SHRINK-WRAPPED TO PREVENT TAMPERING. THE CONTENTS ARE THEN STERILIZED. IN OPERATING ROOM NURSE, REPORTED THAT UPON OPENING THE PRODUCT'S OUTER CARTON THE OR STAFF IMMEDIALTELY RECOGNIZED THAT THE BLUE MOLD WAS NOT INSIDE THE MYLAR/TYVEK POUCH. THE STAFF OPENED ANOTHER CARTON. FOUND THE DEVICE WAS APPROPRIATELY PACKAGED, AND PROCEEDED WITH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGEE STAPES PROSTHESIS ETB GYRUS ENT NA 0211105284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other