BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 20338099 · Received September 30, 2024

    Report

    Report Number
    2210968-2024-10415
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    April 23, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. AN ATTEMPT HAS BEEN 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: JOURNAL OF OBSTETRICS AND GYNAECOLOGY (2022); 42:1, 110-115. HTTPS://DOI.ORG/10.1080/01443615.2020.1867968.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE IN THE ELDERLY: SAFETY AND OUTCOMES. THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO ASSESS OUTCOMES AND PERIOPERATIVE COMPLICATION RATES ASSOCIATED WITH LAPAROSCOPIC SACROCOLPOPEXY (LSC) IN ELDERLY WOMEN. A TOTAL OF 74 WOMEN WHO UNDERWENT LSC FOR POP BETWEEN AUGUST 2015 AND DECEMBER 2017 WERE INCLUDED IN THE STUDY. AMONG THESE, 52 (70.3%) WERE <75 YEARS (MEDIAN AGE, 68 YEARS), AND 22 (29.7%) WERE =75 YEARS (MEDIAN AGE, 77 YEARS). GYNEMESH PS (ETHICON, SOMERVILLE, NJ, USA) WAS USED DURING LSC. THE PERITONEUM WAS CLOSED OVER THE MESHES USING A CONTINUOUS NON-LOCKING 2-0 ABSORBABLE SUTURE (MONOCRYL; ETHICON). RESULTS OF ALL FOLLOW-UP VISITS AT OUR UNIT WERE REVIEWED 3, 6, AND 12 MONTHS AFTER SURGERY. REPORTED COMPLICATIONS INCLUDE INTRAOPERATIVE BLADDER INJURY (N=2) AND VAGINAL INJURY (N=1). POSTOPERATIVE COMPLICATIONS INCLUDE ANATOMICAL RELAPSE/RECURRENCE (N=6), WOUND INFECTION (N=1), PORT-SITE HERNIA (N=3), MESH EROSION (N=1), AND PERSISTENT STRESS URINARY INCONTINENCE (N=3). IN CONCLUSION, THE AUTHORS FINDINGS DEMONSTRATED LOW PERIOPERATIVE MORBIDITY RATES AMONG OLDER WOMEN WHO UNDERWENT LSC FOR POP. AGE SHOULD NOT BE THE BASIS FOR EXCLUSION FROM LAPAROSCOPIC PROCEDURES. MOREOVER, LSC IS A SUITABLE AND VALID OPTION FOR ELDERLY WOMEN WITH POP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34287 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention