BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAUZE SPONGE, 8X4, 12-PLY, BULK

    MDR report key: 6200453 · Received December 22, 2016

    Report

    Report Number
    0001811755-2016-02912
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 22, 2016
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GDY
    PMA / PMN Number
    K060076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGICOUNT SPONGE SHREDDED A PIECE OF SPONGE INTO THE SURGICAL WOUND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850090 GAUZE SPONGE, 8X4, 12-PLY, BULK GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1