BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 ZIPPER TOGA, XL

    MDR report key: 7258724 · Received February 9, 2018

    Report

    Report Number
    0001811755-2018-00403
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 9, 2018
    Report Date
    July 26, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    UDI-DI
    4546540904508
    PMA / PMN Number
    K070078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE TOGA LAYERS DELAMINATED AND RIPPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY, ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE TOGA LAYERS DELAMINATED AND RIPPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY, ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101978 T4 ZIPPER TOGA, XL GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO 17071891 4546540904508

    Patients

    Seq Age Sex Outcome Treatment
    1