BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLYTE HOOD

    MDR report key: 3220912 · Received July 11, 2013

    Report

    Report Number
    0001811755-2013-01625
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 19, 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

    THE NUMBER OF HOODS IN THE REPORTED LOT NUMBER WAS CLARIFIED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE TOGA WAS NOT RETURNED TO THE USER FACILITY AS IT IS NOT A REPAIRABLE PRODUCT.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED UPON PRODUCT RECEIPT THAT TWO HOODS OF THE SAME LOT WERE RECEIVED FOR THE REPORTED EVENT OF FOREIGN MATERIAL IN THE STERILE PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED UPON PRODUCT RECEIPT THAT TWO HOODS OF THE SAME LOT WERE RECEIVED FOR THE REPORTED EVENT OF FOREIGN MATERIAL IN THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320205 FLYTE HOOD GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO 13010115

    Patients

    Seq Age Sex Outcome Treatment
    1