BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 22346493 · Received June 27, 2025

    Report

    Report Number
    2210968-2025-07554
    Event Type
    Injury
    Date Received
    June 27, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J LAPAROENDOSC ADV SURG TECH A. 2024 OCT;34(10):955-959. DOI: 10.1089/LAP.2023.0046. EPUB 2024 APR 18. PMID: 38634643. HTTPS://DOI.ORG/10.1089/LAP.2023.0046.

    Description of Event or Problem · 0

    WE REDUCED THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS IN NEONATAL OSTOMY PATIENTS BY USING SIMPLE DEVICES. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE WHETHER THE INCIDENCE OF COMPLICATIONS AFTER ENTEROSTOMY COULD BE DECREASED WITH A DRAINAGE DEVICE (COMPOSED OF FORESKIN CERCLAGE STAPLE, A CONDOM, AND A 0-MERSILK BRAIDED NONABSORBABLE SUTURE) FIXED IN THE PROXIMAL OSTOMY BOWEL TUBE TO IMPROVE PROXIMAL ENTEROSTOMY IN NEWBORNS. BETWEEN FEBRUARY 2016 AND FEBRUARY 2019,A TOTAL OF 47 PATIENTS WERE INCLUDED IN THE STUDY.THE PATIENTS WERE DIVIDED INTO TWO GROUPS THE MODIFIED SURGERY GROUPS CONSISTS OF 20 CASES AND TRADITIONAL SURGERY GROUPS WITH 27 CASES.THESE INVOLVED 32 BOYS AND 15 GIRLS.THESE PATIENTS USED WITH 0-MERSILK SILK BRAIDED NONABSORBABLE SUTURE (ETHICON 15 · 60 CM).FOLLOW UP AT 3-6 MONTHS. REPORTED COMPLICATIONS: 0-MERSILK SILK BRAIDED NONABSORBABLE SUTURE (ETHICON 15 · 60 CM). -WOUND RELATED DEHISCENCE AND INFECTION(N=10). TREATMENT: NOT REPORTED. -NECROSIS/RETRACTION(N=3). TREATMENT: NOT REPORTED. -LEAK(N=4). TREATMENT: NOT REPORTED. -INTESTINAL PROLAPSE(N=3). TREATMENT: NOT REPORTED. IN CONCLUSIONS, THE PRELIMINARY OBSERVATIONS SUGGESTED THAT THE SIMPLE DRAINAGE DEVICE WAS A SAFE AND EFFECTIVE OPERATION DEVICE THAT REDUCED THE RISK OF STOMA-RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938545 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other