BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 24591541 · Received March 13, 2026

    Report

    Report Number
    2210968-2026-02549
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    July 27, 2025
    Report Date
    April 7, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: WORLD J GASTROINTEST SURG. 2025 JUL 27;17(7):106560. HTTPS://DOI.ORG/10.4240/WJGS.V17.I7.106560. PMID: 40740923; PMCID: PMC12305263.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: IMPACT OF DIFFERENT SKIN SUTURING METHODS ON PATIENT PROGNOSIS AFTER ILEOSTOMY CLOSURE. THE AIM OF THIS STUDY IS TO INVESTIGATE THE IMPACT OF THREE DIFFERENT SKIN SUTURING METHODS AT THE ILEOSTOMY CLOSURE SITE ON PATIENT PROGNOSIS. BETWEEN JANUARY 2024 AND OCTOBER 2024, A TOTAL OF 30 PATIENTS UNDERWENT ILEOSTOMY CLOSURE. THE PATIENTS WERE DIVIDED INTO THREE GROUPS: THE PURSE-STRING SUTURE GROUP, THE CROSS-SUTURE GROUP, AND THE VERTICAL INTERRUPTED SUTURE GROUP, WITH 10 CASES IN EACH GROUP USING 3-0 MONOCRYL SUTURE (ETHICON). REPORTED COMPLICATIONS ARE: N=4; SURGICAL SITE INFECTION. TREATMENT: CONSERVATIVELY TREATED AND RECOVERED. N=1; INTESTINAL OBSTRUCTION. TREATMENT: CONSERVATIVELY TREATED AND RECOVERED. N=7; SUTURE SITE BLEEDING. TREATMENT: CONSERVATIVELY TREATED AND RECOVERED. IN CONCLUSION, USING PURSE-STRING OR CROSS-SUTURING METHODS FOR SKIN INCISION AT THE ILEOSTOMY CLOSURE SITE CAN SHORTEN WOUND HEALING AND SUTURE REMOVAL TIMES, REDUCE SURGICAL SITE INFECTION INCIDENCE AND POSTOPERATIVE INFLAMMATORY RESPONSE, ALLEVIATE INCISION PAIN, AND PROMOTE RAPID POSTOPERATIVE RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658385 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other