BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLYTE HOOD

    MDR report key: 3192886 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01487
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K063005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF EIGHT OUT OF THE NINE HOODS, THE STRING FOUND IN THE NINTH UNIT WAS DETERMINED TO BE PART OF THE STITCHING AND ATTACHED TO THE HOOD. AS THIS THE FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING BEFORE USE, IT WAS DETERMINED THAT A MANUFACTURING ISSUE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE HOODS ARE STERILE SINGLE USE PRODUCTS AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INCOMING INSPECTION AT THE USER FACILITY, FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGING OF THE HOOD. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    UPON PRODUCT RECEIPT, IT WAS CLARIFIED THAT THE REPORTED FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGING OF NINE HOODS OF ONE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292848 FLYTE HOOD GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO 13010110

    Patients

    Seq Age Sex Outcome Treatment
    1