BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP SPONGE

    MDR report key: 1930192 · Received November 9, 2010

    Report

    Report Number
    1030451-2010-00005
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 13, 2010
    Manufacturer
    MEIXIN MEDICAL SUZHOU CO., LTD.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDWATCH (B)(4) STATED "FIBERS FROM A LAP SPONGE WERE FOUND ON THE END OF THE SUCTION HANDLE, CREATING POTENTIAL FOR RETENTION OF THE COTTON FIBER IN THE PT WOUND." NO CONSEQUENCES OR IMPACT TO THE PT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP SPONGE 404, NON-WASHED, 18X18" GDY MEIXIN MEDICAL SUZHOU CO., LTD. 404 PL1005E05

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention