BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 24314887 · Received February 11, 2026

    Report

    Report Number
    2210968-2026-01512
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    August 23, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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: UPDATES SURG. 2025 AUG 23. HTTPS://DOI.ORG/10.1007/S13304-025-02351-6 EPUB AHEAD OF PRINT. PMID: 40847254.

    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: BUT THE ARTICLE FOUND YOUR PRODUCT IS VERY SAFE AND WE ENCOURAGED ITS USE.

    Description of Event or Problem · 0

    TITLE: HEMOPATCH SEROSAL REINFORCEMENT IN RIGHT COLECTOMY: TRANSFORMING ANASTOMOTIC LEAK PATTERNS AND SEVERITY COMPARED TO SECOND-LINE SUTURE TECHNIQUE-A 10-YEAR RETROSPECTIVE COHORT STUDY OF 352 PATIENTS. THIS RETROSPECTIVE COHORT STUDY EVALUATES SAFETY AND LEAK MITIGATION OF HEMOPATCH SEROSAL REINFORCEMENT COMPARED TO CONVENTIONAL SUTURE REINFORCEMENT IN PATIENTS UNDERGOING RIGHT COLECTOMY. BETWEEN JANUARY 2013 AND DECEMBER 2024, A TOTAL OF N=352 PATIENTS UNDERWENT ELECTIVE RIGHT HEMICOLECTOMY. THE MESENTERIC DEFECT WAS CLOSED WITH INTERRUPTED 3¿0 VICRYL IN ALL CASES. FASCIAL CLOSURE EMPLOYED CONTINUOUS 1¿0 PDS WITH ATTEMPTED 4:1 SUTURE-TO-WOUND RATIO. REPORTED COMPLICATIONS ARE: 3¿0 VICRYL, 1¿0 PDS, N=8 ISREC-A CLASSIFICATION LEAK (RADIOLOGIC LEAK REQUIRING NO INTERVENTION), TREATMENT: NOT REPORTED, N=7 ISREC-B CLASSIFICATION LEAK (REQUIRING INTERVENTION WITHOUT RELAPAROTOMY), TREATMENT: UNSPECIFIED INTERVENTION WITHOUT RELAPAROTOMY, N=4 ISREC-C CLASSIFICATION LEAK (REQUIRING RELAPAROTOMY), TREATMENT: RELAPAROTOMY, N=5 UNSPECIFIED CLAVIEN-DINDO CLASSIFICATION = III COMPLICATIONS, TREATMENT: NOT REPORTED, N=19 ANASTOMOTIC LEAK, TREATMENT: N=8 CONSERVATIVE MANAGEMENT (ANTIBIOTICS ONLY), N=7 PERCUTANEOUS DRAINAGE, N=4, RETURN TO OPERATING THEATER, N=3 ANASTOMOTIC STENOSIS, TREATMENT: NOT REPORTED, N=5 SMALL BOWEL OBSTRUCTION, TREATMENT: NOT REPORTED, N= 7 POSTOPERATIVE ILEUS, TREATMENT: NOT REPORTED, N=12 PERI-ANASTOMOTIC ABSCESS, TREATMENT: NOT REPORTED, N=3 ANASTOMOTIC POST-OPERATIVE BLEEDING, TREATMENT: NOT REPORTED. IN CONCLUSION, HEMOPATCH APPEARS TO BE A VIABLE ALTERNATIVE TO TRADITIONAL SUTURE REINFORCEMENT IN RIGHT COLECTOMY ANASTOMOSES, WITH COMPARABLE SAFETY AND A POTENTIAL ADVANTAGE IN REDUCING CLINICALLY SIGNIFICANT LEAKS WITH A GOOD PRO FILE OF SAFETY. RATHER THAN PREVENTING ALL LEAKS, IT TRANSFORMS TECHNICAL FAILURES INTO MORE MANAGEABLE OUTCOMES WITH LESS SEVERE CLINICAL CONSEQUENCES. FURTHER PROSPECTIVE STUDIES ARE NEEDED TO DEFINE OPTIMAL PATIENT SELECTION CRITERIA AND LONG-TERM OUTCOMES. THE STRONG ASSOCIATION BETWEEN OBESITY AND ANASTOMOTIC LEAKAGE WARRANTS FURTHER INVESTIGATION AND MAY REPRESENT AN IMPORTANT TARGET FOR TAILORED SURGICAL APPROACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378258 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention