BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 17424639 · Received July 31, 2023

    Report

    Report Number
    2210968-2023-05504
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    January 1, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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: CITATION: JOURNAL OF CLINICAL NEUROSCIENCE (2014); 21:968¿974. HTTP://DX.DOI.ORG/10.1016/J.JOCN.2013.09.008. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: CAVERNOUS SINUS HEMANGIOMA: A FOURTEEN YEAR SINGLE INSTITUTION EXPERIENCE AUTHORS: SUMIT BANSAL, ASHISH SURI, MANMOHAN SINGH, SHASHANK SHARAD KALE, DEEPAK AGARWAL, MANISH SINGH SHARMA, ASHOK KUMAR MAHAPATRA, BHAWANI SHANKAR SHARMA CITATION: JOURNAL OF CLINICAL NEUROSCIENCE (2014); 21:968¿974. HTTP://DX.DOI.ORG/10.1016/J.JOCN.2013.09.008. THE PURPOSE OF THIS STUDY IS TO REPORT OUR EXPERIENCE OF REMOVAL OF CAVERNOUS SINUS HEMANGIOMA (CSH) THROUGH A COMPLETELY EXTRADURAL TRANSCAVERNOUS APPROACH, WITH USE OF GKRS FOR SMALLER LESIONS OR MEDICALLY UNFIT PATIENTS. BETWEEN 1999 TO 2012, A TOTAL OF 22 PATIENTS (4 MALE AND 18 FEMALE) WITH CSH WERE INCLUDED IN THE STUDY. PATIENTS WERE MANAGED WITH MICROSURGICAL RESECTION USING A PURELY EXTRADURAL TRANSCAVERNOUS APPROACH (N=13) AND WITH GAMMA KNIFE RADIOSURGERY (GKRS; ELEKTA AB, STOCKHOLM, SWEDEN) (N=9). IN ALL 13 SURGICAL PATIENTS, HEMOSTASIS WAS ACHIEVED USING GENTLE PACKING WITH GELATIN (SPONGSTAN; JOHNSON & JOHNSON MEDICAL, NEW YORKSHIRE, UK), DEGRADED CELLULOSE (SURGICEL; JOHNSON & JOHNSON MEDICAL) AND HEMOSTATIC MATRIX (FLOSEAL; BAXTER BIOSURGERY, IL, USA), AND BLOOD LOSS WAS REPLACED USING A CELL SAVER (AUTOTRANFUSION UNIT; DIDECON, MIRANDOLA, ITALY). REPORTED COMPLICATIONS INCLUDE PROFUSE BLOOD LOSS (N=1) IN A 36-YEAR-OLD FEMALE PATIENT. IN CONCLUSION, ALTHOUGH MICROSURGICAL RESECTION USING AN EXTRADURAL TRANSCAVERNOUS APPROACH IS CONSIDERED THE TREATMENT OF CHOICE IN CSH AND ALLOWS COMPLETE EXCISION WITH MINIMAL MORTALITY OR LONG TERM MORBIDITY IN PATIENTS, GKRS IS AN ADDITIONAL TOOL FOR TREATING RESIDUAL SYMPTOMATIC LESIONS OR PATIENTS WITH ASSOCIATED COMORBIDITIES MAKING SURGICAL RESECTION UNSUITABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839130 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention