BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTEC SPG 4X4 NON ST 10S 16PLY

    MDR report key: 6071048 · Received November 1, 2016

    Report

    Report Number
    1018120-2016-00160
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    October 22, 2016
    Manufacturer
    COVIDIEN
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 PAD. THE CUSTOMER REPORTS SPONGES ARE FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722663 VISTEC SPG 4X4 NON ST 10S 16PLY GAUZE SPONGE EFQ COVIDIEN 7148 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1