BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3820072 · Received April 24, 2014

    Report

    Report Number
    3820072
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 14, 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

    WE HAD A NEAR MISS FOR A RETAINED SURGICAL SPONGE. THE RAY-TEC SPONGES IN THIS CUSTOM PACK CONTAINED 11 SPONGES INSTEAD OF 10. SPONGES WERE REMOVED FROM THE STERILE FIELD AND THE OPERATING ROOM. SPONGES AND PACK INFO FORWARDED TO CONTACT MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249468 * SURGICAL SPONGES LWH COVIDIEN LSRHHTOHIPPA 993141

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR