BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 16930315 · Received May 15, 2023

    Report

    Report Number
    2210968-2023-03584
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    January 1, 2022
    Report Date
    May 15, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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: JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION (2022); 121:1223-1230. HTTPS://DOI.ORG/10.1016/J.JFMA.2021.11.010. EVENT RELATED TO MW # 2210968-2023-03583. 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: SURGICAL APPLICATION OF ENDOSCOPIC-ASSISTED MINIMALLY-INVASIVE NEUROSURGERY TO TRAUMATIC BRAIN INJURY: CASE SERIES AND REVIEW OF LITERATURE AUTHORS: WEI-LUNG TSENG A,B,D,1, LU-TING KUO B,1, CHIEN-MIN CHEN E,F, SHIH-HUNG YANG B, CHI-TUN TANG C, DAR-MING LAI B, ABEL PO-HAO HUANG B,* CITATION: JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION (2022); 121:1223-1230. HTTPS://DOI.ORG/10.1016/J.JFMA.2021.11.010 THE AIM OF THIS RETROSPECTIVE MULTI-CENTER STUDY WAS TO REVIEW THE PERTINENT LITERATURE AND SHARE THE AUTHORS' EXPERIENCES ON THE USE OF MINIMALLY-INVASIVE NEUROSURGERY (MIN). BETWEEN JANUARY 2008 AND DECEMBER 2016, A TOTAL OF 22 PATIENTS (14 MALE AND 8 FEMALE; AGED 24-83 YEARS) WITH TRAUMATIC BRAIN INJURY (TBI) WHO UNDERWENT ENDOSCOPIC-ASSISTED MIN AND WERE INCLUDED IN THE STUDY. NINE CASES WERE TICH (40.9%), THREE SDH (13.6%), AND 10 EDH (45.4%). ALL PATIENTS UNDERWENT SURGERY WITHIN 72 H OF INJURY. IN TICH PATIENTS, IF OOZING WAS OBSERVED DURING THE SURGERY, SALINE IRRIGATION WAS USED FOR THREE - 5 MIN. IF FAILED, THE CAVITY WAS FILLED WITH SURGICEL FIBRILLAR (JOHNSON & JOHNSON MEDICAL, PISCATAWAY, NJ, USA). IN CASES WHERE ARTERIAL BLEEDING WAS IDENTIFIED, THE BLEEDER WAS IDENTIFIED AND CAUTERIZED. IN EDH PATIENTS, ENDOSCOPIC DURAL TENTING MAY BE PERFORMED SUBDURALLY THROUGH AN 18-GAUGE NEEDLE, PASSING 4-0 PROLENE THROUGH THE NEEDLE AND THEN TIE THE PROLENE SUTURE TO THE BONE EDGE. DURAL TENTING STITCHES WERE PLACED TO THE BONE EDGE OF THE BURR HOLE AND THE WOUND WAS CLOSED WITHOUT DRAINAGE TUBE PLACEMENT. REPORTED COMPLICATIONS INCLUDE WOUND INFECTION (N=1). IN CONCLUSION, ENDOSCOPIC-ASSISTED MIN IN TBI IS SAFE AND EFFECTIVE IN A CAREFULLY SELECTED GROUP OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475324 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other