BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 HOOD WITH PEEL AWAY FACE

    MDR report key: 2896535 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04116
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 30, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K944393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGE. NO PT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. ANOTHER PRODUCT WAS USED TO CONDUCT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T5 HOOD WITH PEEL AWAY FACE FYA STRYKER INSTRUMENTS KALAMAZOO 12070861

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK