BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 23692907 · Received December 2, 2025

    Report

    Report Number
    2210968-2025-13365
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    January 30, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: DIS COLON RECTUM. 2025 MAY 1;68(5):608-615. HTTPS://DOI.ORG/10.1097/DCR.0000000000003661 EPUB 2025 JAN 30. PMID: 39882785.

    Description of Event or Problem · 0

    TITLE: LONG-TERM OUTCOMES AFTER MINIMALLY INVASIVE VENTRAL RECTOPEXY FOR RECTAL PROLAPSE USING BIOLOGICAL GRAFT PROSTHESIS: A 15-YEAR RETROSPECTIVE COHORT STUDY. THE AIM OF THIS STUDY IS TO ASSESS THE SHORT- AND LONG-TERM SAFETY AND EFFICACY OF BIOLOGICAL GRAFTS IN MINIMALLY INVASIVE VENTRAL RECTOPEXY. BETWEEN JANUARY 1, 2008, AND OCTOBER 5, 2023, UNDER THE CARE OF A SINGLE SURGEON AT A SINGLE TERTIARY HOSPITAL (ST. VINCENT¿S NORTHSIDE PRIVATE HOSPITAL, BRISBANE, QUEENSLAND, AUSTRALIA). A TOTAL OF 366 PATIENTS MET THE INCLUSION CRITERIA WITH A MEDIAN FOLLOW-UP TIME OF 35.5 MONTHS (6¿183). THE MAJORITY OF PATIENTS WERE WOMEN (99.7%) WITH A MEDIAN AGE OF 64 YEARS. SINCE 2014, THE STANDARD TECHNIQUE HAS USED AN L-SHAPED 8-PLY BIODESIGN RECTOPEXY GRAFT (COOK MEDICAL, WEST LAFAYETTE, IN) WITH FIXATION TO THE DISTAL AND MID RECTUM USING 4 ROWS OF 3-0 POLYDIOXANONE SUTURES (PDS; ETHICON) WITH SACRAL FIXATION USING 2-0 PDS WITH THE MOST MEDIAL SUTURE USED TO PERFORM AN ADDITIONAL SUTURED RECTOPEXY. GLUBRAN 2 (GEM SRL, VIAREGGIO, ITALY) WAS THEN APPLIED BETWEEN THE GRAFT AND THE RECTUM AT 2-CM INTERVALS FOR ADDITIONAL FIXATION BEFORE PERITONEAL CLOSURE USING 3-0 PDS. REPORTED COMPLICATIONS ARE : -INTUSSUSCEPTION TREATMENT : NOT PROVIDED. -SOLITARY RECTAL ULCER SYNDROME (SRUS) TREATMENT : NOT PROVIDED. -RECTOCELE (N=1) TREATMENT : NOT PROVIDED. -DISTAL PROLAPSE (N=6) TREATMENT : NOT PROVIDED. -REMAINDER MUCOSAL PROLAPSE ONLY (N=?) TREATMENT : NOT PROVIDED. -PAIN (N=11) TREATMENT : THERE WAS NO LONG-TERM PELVIC PAIN, WITH ALL PAIN RESOLVING WITHIN 3 MONTHS. -ABSCESS (N=11) TREATMENT : REQUIRED A RETURN TO THEATER. -PELVIC HEMATOMA (N=2) TREATMENT : REQUIRED AN ADDITIONAL SECOND RETURN TO THEATER FOR LAPAROSCOPIC WASHOUT. -SMALL BOWEL INJURY (N=2) TREATMENT : REQUIRED A RETURN TO THEATER. -SMALL BOWEL OBSTRUCTION (N=1) TREATMENT : REQUIRED A RETURN TO THEATER. IN CONCLUSION, MINIMALLY INVASIVE VENTRAL RECTOPEXY USING A BIOLOGICAL GRAFT IS BOTH SAFE AND EFFECTIVE, OFFERING ACCEPTABLE SHORT- AND LONG-TERM RECURRENCE RATES AND OVERALL COMPLICATIONS WITH NO GRAFT-RELATED MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900471 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention