BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE

    MDR report key: 25017260 · Received April 28, 2026

    Report

    Report Number
    2210968-2026-04569
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 28, 2026
    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. 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: HERNIA. 2026 MAR 16;30(1):132. HTTPS;//DOI.ORG/10.1007/S10029-026-03608-8. PMID: 41838249; PMCID: PMC12992391.

    Description of Event or Problem · 0

    TITLE: THE APPLICATION OF SINGLE-HOLE LAPAROSCOPIC REPAIR WITH SLOW-ABSORBABLE SUTURE IN THE TREATMENT OF INDIRECT INGUINAL HERNIA IN CHILDREN. THE AIM OF THIS STUDY IS TO ANALYZE AND SUMMARIZE THE SURGICAL PROCESS AND THE OCCURRENCE OF INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS IN CHILDREN WHO UNDERWENT SINGLE-PORT LAPAROSCOPIC INTERNAL RING LIGATION WITH ABSORBABLE SUTURE (ABSORBABLE SUTURE GROUP) AND NON-ABSORBABLE SUTURE (NON-ABSORBABLE SUTURE GROUP) IN OUR CENTER. FROM OCTOBER 2022 TO OCTOBER 2023, A TOTAL OF 1022 CHILDREN WITH UNILATERAL INDIRECT INGUINAL HERNIA. THE PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO DIFFERENT SUTURE MATERIALS: SLOW ABSORBABLE SUTURE GROUP (663 CASES) AND NON-ABSORBABLE SUTURE GROUP (359 CASES). SLOW-ABSORBABLE SUTURE PDS: THIS SUTURE IS PRODUCED BY JOHNSON & JOHNSON (SHANGHAI) MEDICAL PDS II IS A STERILE SYNTHETIC ABSORBABLE SINGLE-FIBER SURGICAL SUTURE MADE OF POLYESTER (POLYDIOXANONE). NON-ABSORBABLE SUTURE MERSILK: THIS SUTURE IS PRODUCED BY JOHNSON & JOHNSON (SHANGHAI) MEDICAL EQUIPMENT CO., LTD., REGISTRATION NO.: 20202020196. JOHNSON & JOHNSON SILK KNITTED NON-ABSORBABLE SUTURE IS MADE BY A SILK KNITTING PROCESS, WHICH GIVES IT HIGH STRENGTH AND DURABILITY. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. REPORTED COMPLICATIONS: PDS II SUTURE (ETHICON): (N=13 (2.0%) RECURRENCE IN SLOW-ABSORBABLE SUTURE MATERIAL GROUP TREATMENT: NOT REPORTED MERSILK (ETHICON): (N=3 (0.8%) RECURRENCE IN NON-ABSORBABLE SUTURE MATERIAL GROUP TREATMENT: NOT REPORTED (N=1) THREE WEEKS AFTER THE OPERATION, AN INFLAMMATORY MASS FORMED DUE TO SUTURE REACTION AT THE INTERNAL RING PUNCTURE SITE. TREATMENT: NOT REPORTED (N=1) SIX WEEKS AFTER THE OPERATION, THE INFLAMMATORY MASS AT THE INTERNAL RING PUNCTURE SITE ULCERATED, AND THE SUTURE KNOTS WERE EXPOSED. TREATMENT: NOT REPORTED IN CONCLUSION, OUR STUDY DEMONSTRATES THAT THE USE OF SLOW ABSORBABLE SUTURES FOR LAPAROSCOPIC HIGH LIGATION OF THE INDIRECT INGUINAL HERNIA IN CHILDREN DOES NOT LEAD TO A STATISTICALLY SIGNIFICANT INCREASE IN RECURRENCE RATES COMPARED TO NON-ABSORBABLE SUTURES, WHILE SIMULTANEOUSLY ELIMINATING THE RISK OF SUTURE KNOT REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10745 SILK SUTURE SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other