BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 19176310 · Received April 24, 2024

    Report

    Report Number
    2210968-2024-04853
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    May 17, 2023
    Report Date
    April 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: INDIAN JOURNAL OF OTOLARYNGOLOGY AND HEAD & NECK SURGERY (2023) 75:2814¿2822; HTTPS://DOI.ORG/10.1007/S12070-023-03866-3. 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: OUR EXPERIENCE IN TRANS NASAL ENDOSCOPIC REPAIR OF ANTERIOR SKULL BASE DEFECTS REINFORCED WITH MULTIPLE LAYERS OF GRAFT MATERIALS AUTHOR(S): YETHIN YEDUKUMAR, RAHUL GUPTA, YAMINI PATEL, R. G. AIYER CITATION: INDIAN JOURNAL OF OTOLARYNGOLOGY AND HEAD & NECK SURGERY (2023) 75:2814¿2822; HTTPS://DOI.ORG/10.1007/S12070-023-03866-3. THIS STUDY AIMS TO DETERMINE THE BEST TECHNIQUE TO REPAIR ANTERIOR SKULL BASE DEFECTS USING VARIOUS GRAFTS. BETWEEN MAY 2019 TO OCTOBER 2021, 17 PATIENTS WHO UNDERWENT ENDOSCOPIC REPAIR OF ANTERIOR SKULL BASE DEFECTS USING VARIOUS GRAFTS WERE INCLUDED IN THE STUDY. THERE WERE 6 MALES AND 11 FEMALES. THE MAJORITY WERE OF THE AGE GROUP 40¿59 YEARS (7 PATIENTS). THE SECOND MOST COMMON AGE GROUP WAS 20¿39 YEARS (6 PATIENTS). THE LEAST COMMON AGE GROUP WAS 0¿19 YEARS (1 PATIENT). 3 PATIENTS WERE OF THE ELDERLY AGE GROUP (= 60YEARS). DURING THE PROCEDURE, AFTER INDUCING THE PATIENT, NASAL ENDOSCOPY WAS DONE WITH O DEGREE ENDOSCOPE OF STORZ. THE SITE OF THE LEAK AND ANTERIOR SKULL BASE DEFECT WAS IDENTIFIED. BIPOLAR CAUTERIZATION IS DONE OVER THAT AREA. DEFECT CLOSURE IS DONE WITH MULTIPLE LAYERS OF GRAFTS. VARIOUS GRAFT MATERIALS USED IN THE STUDY WERE FASCIA LATA IN 14 PATIENTS, THIGH FAT IN 14 PATIENTS, HADAD FLAP IN 8 PATIENTS, SEPTAL CARTILAGE IN 1 PATIENT, NASAL SEPTAL BONE CHIP IN 2 PATIENTS, SEPTAL MUCOSAL FREE FLAP IN 1 PATIENT, SURGICEL (ETHICON) IN 10 PATIENTS AND FIBRIN GLUE 5 PATIENTS. AFTER CHECKING FOR CEREBROSPINAL FLUID LEAK AND AFTER ATTAINING HAEMOSTASIS, BILATERAL BACTERIOSTATIC MEROCELE WAS KEPT. THE EXTERNAL NASAL DRESSING WAS GIVEN. MULTIPLE LAYERS OF GRAFT MATERIALS WERE USED IN ALL PATIENTS FOR EXTRA SUPPORT. REPORTED COMPLICATIONS INCLUDED CEREBROSPINAL FLUID LEAK WITH RHINORRHEA (N=1) AND CONVULSION DUE TO CEREBRAL EDEMA (N=?). IN CONCLUSION, THE SUCCESS OF ANTERIOR SKULL BASE DEFECT REPAIR DEPENDS ON WATERTIGHT DURAL CLOSURE WITH MULTIPLE LAYERS OF GRAFTS TO PREVENT POSTOPERATIVE CEREBROSPINAL FLUID LEAK. ALTHOUGH DEPENDENT ON THE SURGEON¿S PREFERENCE, USUALLY THE SEQUENCE OF AN UNDERLAY FAT - FASCIA LATA - OVERLAY FAT FOLLOWED BY GLUE/GEL FOAM/HADAD FLAP WORKS WELL. EVEN AFTER DISCHARGING THE PATIENT, REGULAR FOLLOW-UP AND EVALUATION ENSURE THAT THE GRAFT IS IN SITU AND THERE IS NO CEREBROSPINAL FLUID LEAK OR OTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583538 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other