BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21407325 · Received February 19, 2025

    Report

    Report Number
    2210968-2025-01768
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    November 4, 2024
    Report Date
    February 19, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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: CAN UROL ASSOC J 2024 NOVEMBER 4; EPUB AHEAD OF PRINT. HTTP://DX.DOI.ORG/10.5489/CUAJ.8899.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). CORRECTED INFORMATION: B1, B2, H1 - EVENT REVIEWED. IT NO LONGER MEETS THE CRITERIA FOR A SERIOUS INJURY. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: TECHNIQUES ¿ TENSION-RELIEVING MICRODOT VASOVASOSTOMIES AND LONGITUDINAL INTUSSUSCEPTED VASOEPIDIDYMOSTOMY VASECTOMY REVERSALS: A FIRST REPORT A RETROSPECTIVE REVIEW OF THE STUDY HYPOTHESIZED THAT HIGH PATENCY RATES COULD BE ACHIEVED BY ADDING TENSION-RELIEVING SUTURES TO THE VASAL ADVENTITIA AND PRECISELY PLACING 10-0 AND 9-0 SUTURES TO FORM THE ANASTOMOSIS. THIS STUDY REPORTS OUR TECHNICAL PATENCY AND LATE FAILURE RATES. BETWEEN MAY 2018 AND SEPTEMBER 2023 VASECTOMY REVERSAL WAS CONDUCTED.A TOTAL OF 159 PATIENTS WERE EVALUATED, OF WHICH 136 PATIENTS MET THE INCLUSION CRITERIA.THE MEAN TIME SINCE VASECTOMY WAS EIGHT YEARS (STANDARD DEVIATION SD 5.50), THE MEAN PATIENT AGE WAS 41 (SD 6.17), AND THE MEAN PARTNER'S AGE WAS 34 (SD 4.63). A SINGLE 5-0 PROLENE STITCH WAS ADDED THROUGH THE VASAL ADVENTITIA TO ACHIEVE A TENSION-FREE ANASTOMOSIS. PATIENTS PERFORM FIRST SEMEN ANALYSIS BETWEEN 6-8 WEEKS POSTOPERATIVELY, THEN EVERY 2-3 MONTHS REPORTED COMPLICATIONS INCLUDES (N=4)PATIENTS HAD A LATE FAILURE FOLLOWING VV AND (N=?) PATIENTS NOT INCLUDED IN THE OVERALL PASSING PATENCY RATE. IN CONCLUSION, TENSION-FREE ANASTOMOSIS AND PRECISE, SYMMETRICAL SUTURE PLACEMENT ARE ESSENTIAL FOR SUCCESSFUL ANASTOMOSES. WE REPORT A TECHNIQUE THAT ACHIEVES HIGH PATENCY RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539879 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other