BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTEC SPG 4X4 STR 10S 16 PLY

    MDR report key: 6155758 · Received December 8, 2016

    Report

    Report Number
    1018120-2016-00177
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Report Date
    November 30, 2016
    Manufacturer
    COVIDIEN
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE. THE CUSTOMER STATES THEY RECEIVED 12 SPONGES INSTEAD OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807315 VISTEC SPG 4X4 STR 10S 16 PLY GAUZE SPONGE EFQ COVIDIEN 7317 16C033362

    Patients

    Seq Age Sex Outcome Treatment
    1