BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 12701060 · Received October 26, 2021

    Report

    Report Number
    2210968-2021-10355
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    January 1, 2009
    Report Date
    October 26, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: SURGICAL TECHNOLOGY INTERNATIONAL (2009); XVIII:75-79

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: USE OF OXIDIZED CELLULOSE HEMOSTATS (SURGICEL¿) TO SUPPORT PARENCHYMAL CLOSURE AND ACHIEVE HEMOSTASIS FOLLOWING PARTIAL NEPHRECTOMY AUTHORS: ASHRAF ABOU-ELELA, PH.D., AHMADMORSY, PH.D., HESHAM BADAWY, PH.D., AND MONGY FATHY, PH.D. CITATION: SURGICAL TECHNOLOGY INTERNATIONAL (2009); XVIII:75-79. THE AIM OF THIS STUDY IS TO DESCRIBE THE AUTHOR'S EXPERIENCE WITH ABSORBABLE OXIDIZED CELLULOSE HEMOSTATS IN OPTIMIZING THE OUTCOME IN NSS. BETWEEN MARCH 2002 AND APRIL 2007, 25 PATIENTS WITH RENAL MASSES UNDERWENT TUMOR RESECTION BY OPEN PARTIAL NEPHRECTOMY. OXIDIZED CELLULOSE HEMOSTATS (SURGICEL¿) WERE USED TO SECURE AND APPLY COMPRESSION TO THE DEFECT. THE MEDIAN PATIENT AGE WAS 56 YEARS (RANGE: 24 TO 71 YEARS). REPORTED COMPLICATION INCLUDES POSTOPERATIVE BLEEDING (N=1) AND BLOOD TRANSFUSION WAS REQUIRED. IN CONCLUSION, IN EXPANDING THE INDICATIONS FOR NSS, THERE IS A NEED TO ESTABLISH RELIABLE TECHNIQUES TO EXCISE THE TUMOR AND PREVENT POSTOPERATIVE COMPLICATIONS EVEN IN LARGER TUMORS. IN THIS CONTEXT, OXIDIZED CELLULOSE HEMOSTATS (SURGICEL¿) HAVE PROVEN TO BE A HIGHLY EFFECTIVE AND EASY-TO-USE INSTRUMENT FOR PREVENTING POSTOPERATIVE BLEEDING AND URINARY FISTULA COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597851 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention