BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24318686 · Received February 11, 2026

    Report

    Report Number
    2210968-2026-01558
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    October 12, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    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. 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 SURG RES. 2025 NOV; 315:973-981. DOI: 10.1016/J.JSS.2025.10.017. EPUB 2025 NOV 10. PMID: 41218377. HTTPS://DOI.ORG/10.1016/J.JSS.2025.10.017.

    Description of Event or Problem · 0

    ASSOCIATION OF MESENTERIC MOLDING SUTURING ON PARASTOMAL HERNIA INCIDENCE: RETROSPECTIVE STUDY. THE AIM OF THIS STUDY IS TO ASSESS THE ASSOCIATION OF MMS (MESENTERIC MOLDING SUTURING) WITH PSH (PARASTOMAL HERNIA) INCIDENCE COMPARED WITH CONVENTIONAL END-COLOSTOMY. BETWEEN JANUARY 2016 AND DECEMBER 2022, A TOTAL OF 2890 PATIENTS WHO UNDERWENT ELECTIVE END-COLOSTOMY USING 3-0 OR 4-0 VICRYL ABSORBABLE SUTURES. REPORTED COMPLICATIONS ARE: N=383; SUBCLINICAL PSH (CT TYPE IA). TREATMENT: NOT REPORTED. N=110; CLINICAL PSH (CT TYPE IB). TREATMENT: NOT REPORTED. N=148; CLINICAL PSH (CT TYPE II). TREATMENT: NOT REPORTED. N=66; CLINICAL PSH (CT TYPE III). TREATMENT: NOT REPORTED. N=?; WOUND INFECTIONS. TREATMENT: NOT REPORTED. N=?; PERISTOMAL SKIN COMPLICATIONS. TREATMENT: NOT REPORTED. N=?; STOMA-RELATED COMPLICATIONS (STOMA NECROSIS, BLEEDING, PROLAPSE, OR RETRACTION). TREATMENT: NOT REPORTED. IN CONCLUSION, THIS RETROSPECTIVE COHORT STUDY DEMONSTRATES THAT MMS WAS ASSOCIATED WITH REDUCED PSH INCIDENCE IN ELECTIVE END- COLOSTOMY PATIENTS WITHOUT BEING ASSOCIATED WITH INCREASED SURGICAL COMPLEXITY OR STOMA-RELATED COMPLICATIONS. THE TECHNIQUE REQUIRES MINIMAL ADDITIONAL SURGICAL SKILL AND AVOIDS THE RISKS AND COSTS ASSOCIATED WITH MESH IMPLANTATION. THESE FINDINGS SUGGEST THAT MMS REPRESENTS A PROMISING ALTERNATIVE FOR PSH PREVENTION IN ELECTIVE COLOSTOMY SURGERY. FUTURE PROSPECTIVE RCTS ARE NEEDED TO FURTHER VALIDATE THESE FINDINGS AND TO COMPARE MMS WITH OTHER PREVENTIVE STRATEGIES, INCLUDING MESH REINFORCEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373782 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other