BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1031946 · Received April 8, 2008

    Report

    Report Number
    1031946
    Event Type
    Malfunction
    Date Received
    April 8, 2008
    Date of Event
    March 6, 2008
    Report Date
    April 8, 2008
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    CUSTOM STERILE ORTHO GENERAL PACK WAS OPENED AND FOUND TO CONTAIN SIX LAP SPONGES INSTEAD OF FIVE. THIS WAS IDENTIFIED DURING SPONGE COUNT PROCESS. EXCESS LAP SPONGE REMOVED FROM FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PACK, SURGICAL, ORTHOPEDIC LRP CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES SOP56ANMDK 252564

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR