BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 HOOD WITH PEEL AWAY FACE

    MDR report key: 3234008 · Received July 18, 2013

    Report

    Report Number
    0001811755-2013-01665
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    April 11, 2013
    Report Date
    January 10, 2025
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K070078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR WAS FOUND IN THE STERILE PACKAGING OF THE HOOD AT THE USER FACILITY UPON RECEIPT OF THE PRODUCT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333234 T5 HOOD WITH PEEL AWAY FACE GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown