BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3820066 · Received April 24, 2014

    Report

    Report Number
    3820066
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 24, 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

    MAJOR BASIN PACK OPENED ON BACK FIELD FOR CASE. FIRST COUNT NOTED INCORRECT RAY-TEC COUNT FROM MAJOR BASIN PACK. 9 OUT OF 10 RAY-TEC COUNTED TWICE PRIOR TO START OF CASE. RAY-TECS REMOVED FROM ROOM. MAJOR BASIN PACK INSERT OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249473 * SURGICAL SPONGES LWH COVIDIEN LSRHHMAJBAA 998141

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR