BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 14471371 · Received May 23, 2022

    Report

    Report Number
    2210968-2022-03984
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    November 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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? 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. COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ANHUI MEDICAL JOURNAL, VOLUME 42, NUMBER 11, NOV 2021, PAGES 1264-1267. DOI: 10. 3969/J. ISSN. 1000 - 0399. 2021. 11. 014.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF EFFICACY OF 2 KINDS OF TREATMENT FOR SEVERE UTERINE PROLAPSE THIS STUDY AIMED TO COMPARE THE EFFICACY OF COMBINED MODIFIED TOTAL PELVIC FLOOR RECONSTRUCTION AND Y-SHAPED POLYPROPYLENE MESH LAPAROSCOPIC VAGINOSACRAL FIXATION IN THE TREATMENT OF SEVERE UTERINE PROLAPSE. FROM JUNE 2015 TO DECEMBER 2019, 88 PATIENTS WITH SEVERE UTERINE PROLAPSE WERE INCLUDED IN THE STUDY. THEY WERE DIVIDED INTO RECONSTRUCTION GROUP (N = 60, MEAN AGE 61.98+/-9.11 YEARS) AND LAPAROSCOPY GROUP (N = 28, MEAN AGE 59.46+/-8.57 YEARS) ACCORDING TO DIFFERENT SURGICAL METHODS. IN THE RECONSTRUCTION GROUP, THE TRIMMED POLYPROPYLENE MESH WAS USED IN A BUTTERFLY SHAPE AND STRIP. THE PATIENTS WERE TREATED WITH MODIFIED TOTAL PELVIC FLOOR RECONSTRUCTION USING THE SHAPE COOPERATIVE METHOD, AND THE LAPAROSCOPIC GROUP WAS TREATED WITH CUTTING POLYPROPYLENE MESH WITH SCISSORS AND SUTURED INTO Y-SHAPE FOR LAPAROSCOPIC VAGINOSACRAL FIXATION SURGERY. THE MESH MATERIAL USED WAS THE GYNECARE GYNEMESH PS (ETHICON) 15 CM X 10 CM MESH. AN UNKNOWN 2-0 ABSORBABLE SUTURE (ETHICON) WAS USED TO STITCH THE Y-SHAPED MESH CAUDAL TO THE ANTERIOR LONGITUDINAL SACRAL LIGAMENT. COMPLICATIONS INCLUDE RECURRENCE OF UTERINE PROLAPSE (N=3), MESH EXPOSURE (N=7), POSTOPERATIVE INFECTION (N=2), HEMATOMA (N=1), CHRONIC PELVIC PAIN (N=3). IN CONCLUSION, BOTH METHODS ARE EFFECTIVE IN THE TREATMENT OF SEVERE UTERINE PROLAPSE. THE ANATOMICAL RECOVERY OF MODIFIED TOTAL PELVIC FLOOR RECONSTRUCTION IS SUPERIOR TO THAT OF Y-SHAPED POLYPROPYLENE MESH LAPAROSCOPIC VAGINOSACRAL FIXATION, BUT THE PATIENTS' POSTOPERATIVE SEXUAL SATISFACTION IS SLIGHTLY WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563861 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female