BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 17987298 · Received October 23, 2023

    Report

    Report Number
    2210968-2023-08109
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    July 31, 2023
    Report Date
    October 23, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: LAND SURG 2023;12(7):905-916 / HTTPS://DX.DOI.ORG/10.21037/GS-22-675. 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: THE NOVEL USE AND FEASIBILITY OF HEMOSTATIC OXIDIZED REGENERATED CELLULOSE AGENT (SURGIGUARD® ): MULTICENTER RETROSPECTIVE STUDY. AUTHORS: SEOUNG YOON RHO1, MIRYUNG JIN, HYUN KOO KIM, JEONG-IK PARK, JONG-HWA PARK, SANGCHUL YUN, MARIA LEE, SAE BYEOL CHOI, JAE-YOUNG HONG, KYUNG SIK KIM. CITATION: GLAND SURG 2023;12(7):905-916 / HTTPS://DX.DOI.ORG/10.21037/GS-22-675. THE OBJECTIVE OF THIS STUDY IS TO CONFIRM THAT THE USE OF SURGIGUARD® ALONE IS EFFECTIVE, SAFE AND FEASIBLE COMPARED TO COMBINATION WITH OTHER HEMOSTATIC METHODS. BETWEEN JANUARY 2018 AND DECEMBER 2018, A TOTAL OF 807 PATIENTS WERE ENROLLED; 447 PATIENTS HAD COMORBIDITIES. NINE PATIENTS REPORTED ADVERSE EFFECTS, SUCH AS ABSCESS, BLEEDING, OR LEG SWELLING, BUT WE FOUND NO DIRECT CORRELATION WITH SURGIGUARD®. DUE TO BIOCOMPATIBILITY, BIODEGRADABILITY, LOW TOXICITY, AND RELATIVELY LOW COST, ORC HAS BEEN WIDELY USED IN MEDICAL PRODUCTS, SUCH AS HEMOSTATIC AGENTS, WOUND DRESSINGS, AND DRUG CARRIERS. IN THE 1960S, SURGICEL® (JOHNSON AND JOHNSON, NEW BRUNSWICK, NJ, USA) WAS INTRODUCED TO THE CLINICAL MARKET AS THE FIRST ORC-DERIVED HEMOSTATIC AGENT. SINCE THEN, ORC HAS EVOLVED INTO A GLOBALLY USED TOPICAL HEMOSTATIC AGENTS. REPORTED COMPLICATIONS INCLUDED BLEEDING/LEAKAGE FROM TREATED SITE (N=?), POSTOPERATIVE INTESTINAL OBSTRUCTION (N=?), ABSCESS (N=?), FEVER (N=?), LEG SWELLING (N=?), RESPIRATORY DYSFUNCTION (N=?). IN CONCLUSION, SURGIGUARD® EXHIBITED GREATER EFFECTIVENESS WHEN USED ALONE. NO DIRECT ADVERSE EFFECTS ASSOCIATED WITH SURGIGUARD® USE WERE REPORTED, AND SURGIGUARD® HAD STABLE FEASIBILITY. PROSPECTIVE COMPARATIVE STUDIES ARE NEEDED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069931 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention