BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 HOOD

    MDR report key: 5466493 · Received February 29, 2016

    Report

    Report Number
    0001811755-2016-00244
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    December 30, 2015
    Report Date
    February 3, 2016
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K070078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED; A HAIR WAS FOUND IN THE STERILE PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION BEFORE A SURGICAL PROCEDURE AT THE USER FACILITY, A HAIR WAS FOUND INSIDE THE STERILE PACKAGING. THE HAIR WAS FOUND PRIOR TO OPENING THE PACKAGE. 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 UPON INSPECTION BEFORE A SURGICAL PROCEDURE AT THE USER FACILITY, A HAIR WAS FOUND INSIDE THE STERILE PACKAGING. THE HAIR WAS FOUND PRIOR TO OPENING THE PACKAGE. 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
    125400 T4 HOOD GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO 150081486

    Patients

    Seq Age Sex Outcome Treatment
    1