BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3820069 · Received April 24, 2014

    Report

    Report Number
    3820069
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 12, 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

    THE CUSTOM LAPAROSCOPIC CHOLECYSTECTOMY PACK ONLY HAD 9 RAY-TEC SPONGES INSTEAD OF 10. THE SPONGES WERE SAVED AND GIVEN TO MATERIALS MANAGEMENT TO CONTACT THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249474 * SURGICAL SPONGES LWH COVIDIEN LSRHHLAPCHG *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR