BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 22198341 · Received June 12, 2025

    Report

    Report Number
    2210968-2025-06786
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    April 21, 2024
    Report Date
    June 12, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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: INT J UROL. 2024 JUL;31(7):813-818. HTTPS://DOI.ORG/10.1111/IJU.15471. EPUB 2024 APR 21. PMID: 38644653.

    Description of Event or Problem · 0

    TITLE: BRICKER VERSUS WALLACE URETEROILEAL ANASTOMOSIS: A MULTI-INSTITUTIONAL PROPENSITY SCORE-MATCHED ANALYSIS. THIS RETROSPECTIVE STUDY AIMS TO EVALUATE THE DIFFERENCE IN STRICTURE RATE BETWEEN MATCHED GROUPS OF BRICKER AND WALLACE TECHNIQUES FOR URETEROILEAL ANASTOMOSIS. BETWEEN JANUARY 2004 AND APRIL 2022, A TOTAL OF 740 PATIENTS UNDERWENT CYSTECTOMY AND ILEAL URINARY DIVERSION (UD) IN THE FORM OF CONDUIT, ORTHOTOPIC BLADDER SUBSTITUTION (OBS), OR CONTINENT CUTANEOUS DIVERSION (CCD). ABSORBABLE 4-0 PDS OR VICRYL SUTURES WERE USED IN BOTH TECHNIQUES. REPORTED COMPLICATIONS ARE 4-0 PDS (ETH) VICRYL SUTURES (ETH) BILATERAL STRICTURE N=16 TREATMENT: NOT REPORTED 30 DAY- CLAVAIAN GRADE GREATER THAN OR EQUAL TO III COMPLICATIONS N=176 TREATMENT: NOT REPORTED URINARY LEAKAGE, ABDOMINAL ABSCESS, AND INTESTINAL LEAKAGE N=49 TREATMENT: NOT REPORTED. IN CONCLUSION, DESPITE THE PREVIOUS LIMITATIONS, WE WERE ABLE TO POINT OUT THE RISK ASSOCIATED WITH PERFORMING WALLACE, NAMELY THE HIGHER INCIDENCE OF BILATERAL UPPER TRACT DISEASE. IF THE SURGEON IS UNSURE ABOUT USING ONE OF BOTH TECHNIQUES, WE RECOMMEND A CAREFUL SELECTION OF THE ANASTOMOSIS BASED PATIENT CHARACTERISTICS AND INTRAOPERATIVE FINDINGS; PATIENTS WITH RISK FACTORS FOR THE LATER DEVELOPMENT OF UES, FOR EXAMPLE, PREVIOUS RADIOTHERAPY SHOULD BE OFFERED BRICKER ANASTOMOSIS. FINALLY, WE BELIEVE THAT BRICKER¿S ANASTOMOSIS IS SAFER FOR SURGEONS IN THE EARLY LEARNING PHASE, AS THE TECHNICAL ERRORS DOES NOT AFFECT BOTH RENAL UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805799 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention