BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 ZIPPER TOGA, L/XL

    MDR report key: 7279020 · Received February 16, 2018

    Report

    Report Number
    0001811755-2018-00425
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 19, 2018
    Report Date
    February 16, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    UDI-DI
    4546540152688
    PMA / PMN Number
    K070078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCARDED AT ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY, THE TOGAS WERE TEARING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119750 T4 ZIPPER TOGA, L/XL GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN 4546540152688

    Patients

    Seq Age Sex Outcome Treatment
    1