BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3820068 · Received April 24, 2014

    Report

    Report Number
    3820068
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 20, 2014
    Report Date
    April 24, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS WAS A NEAR MISS. WHILE STAFF MEMBERS WERE CONDUCTING THE INITIAL COUNT, THEY NOTED THAT THE RAY-TECS THAT CAME IN THE PACK CONTAINED 11 SPONGES. THE SPONGES AND PACKAGING WERE REMOVED FROM THE ROOM AND THE SPONGE COUNT WAS DONE AGAIN WITH A NEW PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249542 * SURGICAL SPONGES LWH COVIDIEN LSRHHVAGPEA 683131

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR