BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN NEURO SPONGES

    MDR report key: 6993474 · Received November 1, 2017

    Report

    Report Number
    MW5073064
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 11, 2017
    Manufacturer
    CODMAN AND SHURTLEFF NEURO SPONGES
    Product Code
    GEL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE OPERATING ROOM CREW WERE COUNTING DURING SET UP OF A PROCEDURE AND FOUND THAT WHEN COUNTING THERE WERE 11 NEURO SPONGES IN THE PACK INSTEAD OF 10. THIS WAS FOUND PRIOR TO A PATIENT BEING BROUGHT INTO THE OPERATING ROOM. OPERATING ROOM HAD SAVED THE SPONGES BUT SINCE THAT TIME THEY HAVE BEEN UNABLE TO LOCATE THEM. THEREFORE THE SPONGES ARE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774135 CODMAN NEURO SPONGES NEURO SPONGES GEL CODMAN AND SHURTLEFF NEURO SPONGES

    Patients

    Seq Age Sex Outcome Treatment
    1