BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1599482 · Received February 10, 2010

    Report

    Report Number
    1599482
    Date Received
    February 10, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 9, 2010
    Manufacturer
    SRI/SURGICAL EXPRESS, INC.
    Product Code
    EFQ
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THERE WERE 6 SPONGES FOUND IN A SPONGE PACK (USUALLY 5 SPONGES)DURING 1ST COUNT BEFORE THE CASE START FROM BASIC PUMP PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SPONGE, LAPAROSCOPY EFQ SRI/SURGICAL EXPRESS, INC. N/A 906507

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR