BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 HOOD

    MDR report key: 5092393 · Received September 21, 2015

    Report

    Report Number
    0001811755-2015-03489
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE WAS NOT RECEIVED IN THE ORIGINAL STERILE PACKAGING, A ROOT CAUSE CAN NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF THE PRODUCT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF THE PRODUCT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621589 T4 HOOD GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO 14111823

    Patients

    Seq Age Sex Outcome Treatment
    1