BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPONGE: LAP 18" - 18"

    MDR report key: 4380541 · Received October 14, 2014

    Report

    Report Number
    1030451-2014-00009
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEIXIN MEDICAL SUZHOU CO.,
    Product Code
    GDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): MEDICAL ACTION INDUSTRIES INC. IS SUBMITTING THIS REPORT ON BEHALF OF MEIXIN MEDICAL SUZHOU CO. LTD (MFR). UPON RECEIPT OF THIS COMPLAINT ON (B)(6)2014, MAI IMMEDIATELY OPENED COMPLAINT #(B)(4) AND BEGAN THE INVESTIGATION. MAI DID NOT RECEIVE A LOT NUMBER OR SAMPLE FOR THIS COMPLAINT; THEREFORE, THE INVESTIGATION WAS LIMITED TO EXAMINATION OF SAMPLES FROM CURRENT INVENTORY. THESE SAMPLES MET ALL SPECS WITH NO FAILURES. REVIEW OF COMPLAINT HISTORY FOR THIS ITEM OVER THE LAST SEVERAL YEARS SHOWS NO PAST COMPLAINTS FOR THIS ISSUE. ALL TEAM MEMBERS RESPONSIBLE FOR THIS PRODUCT LINE WERE NOTIFIED OF THIS COMPLAINT FOR AWARENESS. MEIXIN MEDICAL, THE MFR, HAS ALSO BEEN NOTIFIED OF THIS ISSUE FOR AWARENESS. MAI HAS ENTERED THIS ISSUE INTO OUR DATABASE AND WILL CONTINUE TO TRACK FOR ANY RELATED TRENDS.

    Description of Event or Problem · 1

    PIECES OF STRING FROM A LAPAROSTOMY SPONGE FELL INTO THE SURGICAL WOUND DURING AN OPERATION. THE STRINGS WERE SUCCESSFULLY REMOVED BEFORE THE SURGICAL WOUND WAS CLOSED. THE PT REQUIRED NO TESTING OR EXTENDED CARE AS A RESULT OF THIS EVENT. TO DATE, THERE HAVE BEEN NO REPORTS OF INFECTION OR OTHER EVENT-RELATED ISSUES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652116 SPONGE: LAP 18" - 18" LAP SPONGE GDY MEIXIN MEDICAL SUZHOU CO., V450 NONE PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention