BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 15674435 · Received October 26, 2022

    Report

    Report Number
    2210968-2022-08789
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    September 22, 2020
    Report Date
    October 26, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. 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. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH 2021;31:479¿484.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC VENTRAL MESH RECTOPEXY (LVMR) FOR INTERNAL AND EXTERNAL RECTAL PROLAPSE: AN ANALYSIS OF 122 CONSECUTIVE PATIENTS. THIS STUDY AIMS TO TO EVALUATE THE RESULTS OF LVMR IN PATIENTS WITH IRP AND ERP. FROM SEPTEMBER 2013 TO JANUARY 2019, 122 PATIENTS WITH IRP (N=48) OR ERP (N=74) UNDERWENT LVMR. THE SURGICAL TECHNIQUE WAS BASED ON A STUDY BY D¿HOORE AND PENNINCKX WITH SOME MODIFICATIONS. THE PATIENTS UNDERWENT LVMR WITH POLYPROPYLENE MESH (PARIETEX FLAT SHEET MESH;MEDTRONIC, MN). THE MESH WAS DESIGNED IN THE SHAPE OF A GOLF CLUB FOR EACH PATIENT. IT WAS SECURED TO THE RECTUM AND VAGINA WITH INTERRUPTED ABSORBABLE SUTURES (POLYDIOXANONE; ETHICON). REPORTED COMPLICATIONS INCLUDED VOIDING DIFFICULTIES WITH IMPOTENCE (N=2), RECURRENT FULLTHICKNESS PROLAPSE (N=8) IN CONCLUSION LVMR IS A FEASIBLE AND SAFE TECHNIQUE WITH FAVORABLE RECURRENCE FOR ERP. FUNCTIONAL OUTCOMES OF OD AND FI WERE IMPROVED IN >50% OF THE PATIENTS WHO UNDERWENT LVMR FOR IRP. THEIR SATISFACTION SCORES WERE HIGH AFTER SURGERY. LVMR CAN BE A RECOMMENDED SURGICAL OPTION FOR THE TREATMENT OF ERP AND IRP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599520 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention