BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 HOOD

    MDR report key: 3292305 · Received August 16, 2013

    Report

    Report Number
    0001811755-2013-01962
    Event Type
    Malfunction
    Date Received
    August 16, 2013
    Date of Event
    July 23, 2013
    Report Date
    July 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K070078
    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

    THIS WAS DETERMINED TO BE A DUPLICATE EMDR REPORT. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT NUMBER 0001811755-2013-01960. MANUFACTURER REPORT NUMBER 0001811755-2013-01960 STATED THE FOLLOWING: DURING THE VISUAL INSPECTION OF THE PRODUCT, FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH. A MANUFACTURING ISSUE WAS DETERMINED TO BE A PROBABLE CAUSE OF THE FOREIGN MATERIAL IN THE PACKAGING. THE HOOD IS A SINGLE USE PRODUCT AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF THE TOGA. THE PROCEDURE WAS PERFORMED USING BACK-UP PRODUCT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS EVENT WAS PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT NUMBER 0001811755-2013-01960. IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF THE TOGA. THE PROCEDURE WAS PERFORMED USING BACK-UP PRODUCT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398367 T4 HOOD GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO 13050689

    Patients

    Seq Age Sex Outcome Treatment
    1