BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 22371820 · Received July 1, 2025

    Report

    Report Number
    2210968-2025-07677
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    February 20, 2024
    Report Date
    July 1, 2025
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: INTERNATIONAL JOURNAL OF LIFE SCIENCES, BIOTECHNOLOGY AND PHARMA RESEARCH VOL. 13, NO. 3, MARCH 2024.

    Description of Event or Problem · 0

    TITLE: TO COMPARE THE EFFECTIVENESS OF SUBCUTANEOUS NEGATIVE PRESSURE WITH SIMPLE CLOSURE OF THE SKIN INCISION IN PATIENTS UNDERGOING SURGERY FOR HOLLOW VISCUS PERFORATION. THE AIM OF THIS STUDY IS TO COMPARE THE EFFECTIVENESS OF SUBCUTANEOUS NEGATIVE PRESSURE WITH SIMPLE CLOSURE OF THE SKIN INCISION IN PATIENTS UNDERGOING SURGERY FOR HOLLOW VISCUS PERFORATION. A TOTAL OF 100 PATIENTS HAD EMERGENCY LAPAROTOMY, WITH 50 OF THEM RECEIVING A CLOSED SUBCUTANEOUS DRAIN USING 2-0 MERSILK SUTURE MATERIAL. ANOTHER 50 INDIVIDUALS HAD PRIMARY CLOSURE OF THE SKIN INCISION. REPORTED COMPLICATIONS ARE: N=2; SEROMA TREATMENT: NOT MENTIONED N=2; HEMATOMA TREATMENT: NOT MENTIONED N=6; SSI (SURGICAL SITE INFECTION) TREATMENT: NOT MENTIONED N=2; WOUND DEHISCENCE TREATMENT: NOT MENTIONED IN CONCLUSION, OUR RESEARCH DEMONSTRATES THAT THE USE OF SUBCUTANEOUS NEGATIVE PRESSURE DRAINAGE EFFECTIVELY DECREASES THE OCCURRENCE OF SURGICAL SITE INFECTION AND SHORTENS THE LENGTH OF HOSPITALIZATION AFTER SURGERY FOR HOLLOW VISCUS PERFORATION. THIS INTERVENTION FACILITATES PROMPT RECOVERY, ENHANCES WOUND HEALING, AND REDUCES THE FINANCIAL BURDEN ON PATIENTS BY MINIMIZING HOSPITALIZATION AND INFECTION. DUE TO THE CORRELATION BETWEEN POST-OPERATIVE PROBLEMS AND THE DEGREE OF CONTAMINATION, WE ADVISE THE USE OF CLOSED NEGATIVE PRESSURE SUBCUTANEOUS DRAIN IN ALL PATIENTS WITH CONTAMINATED OR UNCLEAN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357532 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other