BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 23717758 · Received December 4, 2025

    Report

    Report Number
    2210968-2025-13607
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    May 9, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: SURG ONCOL. 2025 JUN;60:102229. DOI: 10.1016/J.SURONC.2025.102229. EPUB 2025 MAY 9. PMID: 40373642. HTTPS://DOI.ORG/10.1016/J.SURONC.2025.102229.

    Description of Event or Problem · 0

    RISK FACTORS FOR POSTOPERATIVE EVISCERATION AFTER CYTOREDUCTIVE SURGERY AND HIPEC. A COMPARATIVE STUDY OF OPEN AND CLOSED ABDOMINAL TECHNIQUES. THE AIM OF THIS STUDY IS TO IDENTIFY RISK FACTORS ASSOCIATED WITH EVISCERATION AFTER OPEN AND CLOSED HIPEC (HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY) TECHNIQUES. BETWEEN JANUARY 2014 AND DECEMBER 2023, 233 PATIENTS INCLUDED IN THE STUDY (OPEN_HIPEC, N = 110 OR CLOSED_HIPEC, N = 123). THEIR MEDIAN AGE WAS 60 [51; 67] YEARS; 129 (55.4 %) WERE FEMALE. THE SUTURE MATERIAL USED FOR OPEN_HIPEC WAS: VICRYL 0, VICRYL 1, PDS 0, PDS 1, PDS 2, PDS 1 OR PDS BOUCLE IN 1 (0.9 %), 39 (35.4 %), 5 (4.6 %), 43 (39.1 %), 1 (0.9 %), AND 21 (19.1 %) PROCEDURES, RESPECTIVELY; AND FOR CLOSED_HIPEC:, VICRYL 1, VICRYL 2/0, PDS 1, PDS 1 BOUCLE OR MONOTIME 1 IN 20 (17.9 %), 2 (1.8 %), 1 (0.9 %), 66 (58.9 %), 23 (20.5 %) PROCEDURES, RESPECTIVELY; P = =0.001. REPORTED COMPLICATIONS ARE THE FOLLOWING: VICRYL SUTURE (0 OR 1 OR 2/0; ETHICON) - EVISCERATION AT DAY 30 IN OPEN_HIPEC (N=7) TREATMENT: REINTERVENTION AND CHANGE TO PDS SUTURES. - GRADE (3¿4) DINDO-CLAVIEN COMPLICATION AT DAY 30 IN OPEN_HIPEC (N=17) TREATMENT: NOT REPORTED - UNKNOWN EVENT AT DAY 30 IN OPEN_HIPEC (N=11) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD READMISSION AT 30 DAYS WITH UNKNOWN CAUSE - GRADE (3¿4) DINDO-CLAVIEN COMPLICATION AT DAY 30 IN CLOSED_HIPEC (N=?) TREATMENT: NOT REPORTED - UNKNOWN EVENT AT DAY 30 IN CLOSED_HIPEC (N=?) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD READMISSION AT 30 DAYS WITH UNKNOWN CAUSE. PDS SUTURE (0 OR 1 OR 2 OR 1 BOUCLE; ETHICON) - GRADE (3¿4) DINDO-CLAVIEN COMPLICATION AT DAY 30 IN OPEN_HIPEC (N=17) TREATMENT: NOT REPORTED - UNKNOWN EVENT AT DAY 30 IN OPEN_HIPEC (N=11) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD READMISSION AT 30 DAYS WITH UNKNOWN CAUSE - GRADE (3¿4) DINDO-CLAVIEN COMPLICATION AT DAY 30 IN CLOSED_HIPEC (N=?) TREATMENT: NOT REPORTED - UNKNOWN EVENT AT DAY 30 IN CLOSED_HIPEC (N=?) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD READMISSION AT 30 DAYS WITH UNKNOWN CAUSE. IN CONCLUSION, FOR CRS/HIPEC TREATMENT, OUR STUDY SHOWS THAT 3.4 % OF PATIENTS HAD EVISCERATION BY DAY 30. A COPD/RESPIRATORY PATHOLOGY AND THE OPEN_HIPEC TECHNIQUE WERE IDENTIFIED AS INDEPENDENT RISK FACTORS LINKED TO EVISCERATION. IT SHOULD ALSO BE NOTED THAT IN THE OPEN_HIPEC GROUP THERE WERE NO EVISCERATIONS AFTER THE CHANGE TO PDS SUTURES. THESE INSIGHTS ADVOCATE FOR STANDARDIZED CLOSURE TECHNIQUES AND PREOPERATIVE PLANNING, ESPECIALLY IN PATIENTS WITH RESPIRATORY COMORBIDITIES, TO IMPROVE SURGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949817 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R