BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 18209849 · Received November 27, 2023

    Report

    Report Number
    2210968-2023-09189
    Event Type
    Death
    Date Received
    November 27, 2023
    Date of Event
    February 26, 2023
    Report Date
    November 27, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO ADDITIONAL INFORMAITON WAS PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: CITATION: JOURNAL OF CARDIOVASCULAR DISEASE RESEARCH (2023);14(3):646-651. PLEASE SEE ARTICLE ATTACHED. RELATED MEDWATCH REPORTS: 2210968-2023-09185, 2210968-2023-09186, 2210968-2023-09187 AND 2210968-2023-09188.

    Description of Event or Problem · 0

    TITLE: A PROSPECTIVE COMPARATIVE STUDY OF SINGLE LAYER VS DOUBLE LAYER HAND SEWN INTESTINAL ANASTOMOSIS THIS COMPARATIVE STUDY ENDEAVOURS TO COMPARE OUTCOME OF SINGLE LAYER VERSUS DOUBLE LAYER INTESTINAL ANASTOMOSIS IN SMALL AND LARGE BOWEL IN TERMS OF DURATION REQUIRED TO PERFORM INTESTINAL ANASTOMOSIS, POST OPERATIVE COMPLICATIONS LIKE ANASTOMOTIC LEAK, DURATION OF HOSPITAL STAY IN EACH GROUP. BETWEEN MAY 2021 TO JULY 2022, A TOTAL OF 50 PATIENTS WITH VARIOUS CLINICAL CONDITIONS REQUIRING RESECTION AND ANASTOMOSIS OF SMALL AND LARGE BOWEL WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE GROUPED ACCORDING TO SINGLE LAYER ANASTOMOSIS (GROUP A; N=25; 17 MALES AND 8 FEMALES) AND DOUBLE LAYER ANASTOMOSIS (GROUP B; N=25; 15 MALES AND 10 FEMALES). INTESTINAL ANASTOMOSIS WAS CARRIED OUT IN SINGLE LAYER CONTINUOUS EXTRAMUCOSAL TECHNIQUE WITH 3-0 PDS AND DOUBLE LAYER CONTINUOUS TECHNIQUE WITH 3-0 VICRYL TAKING THROUGH ALL LAYERS AND SEROMUCUSULAR LAYER WITH 3-0 MERSILK. REPORTED COMPLICATIONS INCLUDE ANASTOMOTIC LEAK (N=2), 1 EACH IN GROUP A AND B, AND DEATH DUE TO SEPTICAEMIA SECONDARY TO ANASTOMOTIC LEAK (N=1) IN GROUP B ONLY. IN CONCLUSION, DURATION REQUIRED TO PERFORM A SINGLE LAYER INTESTINAL ANASTOMOSIS IS SIGNIFICANTLY LESSER WHEN COMPARED TO DOUBLE LAYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498291 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death