BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH M UNKNOWN PRODUCT

    MDR report key: 20334916 · Received September 30, 2024

    Report

    Report Number
    2210968-2024-10399
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    January 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    PMA / PMN Number
    K082216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: HTTPS://DOI.ORG/10.1186/S12905-022-02105-1.

    Description of Event or Problem · 0

    TITLE: MEDIUM TO LONG TERM OUTCOMES OF VAGINALLY ASSISTED LAPAROSCOPIC SACROCOLPOPEXY IN THE TREATMENT OF STAGE III¿IV PELVIC ORGAN PROLAPSE. THE AIMED TO INVESTIGATE THE MEDIUM- TO LONG-TERM EFFICACY AND SAFETY OF VALS FOR TREATING STAGE III¿IV PELVIC ORGAN PROLAPSE (POP). THE STUDY WAS DESIGNED AS A CASE SERIES AT A SINGLE CENTER. PATIENTS WITH STAGE III¿IV POP IN OUR HOSPITAL FROM JANUARY 2010 TO DECEMBER 2018 WERE INCLUDED. PERIOPERATIVE PARAMETERS, OBJECTIVE AND SUBJECTIVE OUTCOMES, AND COMPLICATIONS WERE ASSESSED. THE MEAN AGE WAS 55.86±8.48 YEARS, BODY MASS INDEX (BMI) WAS 24.10±2.89 KG/M², MEDIAN PARITY WAS 2 (RANGING FROM 1 TO 6), AND MEDIAN FOLLOW-UP PERIOD WAS 3 5.40 MONTHS (RANGING FROM 12.13 TO 109.97 MONTHS). THE SACRO COLPOPEXY IS CONDUCTED USING GYNEMESH (GYNECARE, ETHICON, SOMERVILLE, NJ, USA) AND ¿Y¿ TYPE MESH (ARTISYN; JOHNSON & JOHNSON INTERNATIONAL, C/O EUROPEAN LOGISTICS CENTRE, DIEGEM, BELGIUM). THE ANTERIOR GYNEMESH IS CUT INTO A 3.5 CM * 12.0 CM BOOT-SHAPED MESH WITH A 3 CM * 5 CM BOOT BOTTOM, AND THE POSTERIOR GYNEMESH IS CUT INTO A 3.5 CM * 12.0 CM OBLONG-SHAPED MESH. BOTH GYNEMESH AND ¿Y¿ TYPE MESHES ARE MODIFIED ACCORDING TO PATIENTS¿ ANATOMIC FEATURES. THE REPORTED COMPLICATIONS INCLUDED: (N=3) FEVER, TREATMENT: NOT MENTIONED. (N=1) INFECTION, TREATMENT: NOT MENTIONED. (N=6) MESH EXPOSURE, TREATMENT: MESH REMOVAL. IN CONCLUSION, VALS IS AN EFFECTIVE AND SAFE PROCEDURE FOR TREATING SEVERE POP. THEREFORE, VALS OPERATIONS SHOULD BE CONSIDERED FOR TREATING SEVERE POP DUE TO ITS FAVORABLE SUBJECTIVE AND OBJECTIVE OUTCOMES, LOW RATE OF INFECTION AND ACCEPTABLE RATE OF MESH EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603675 GYNECARE GYNEMESH M UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC GAL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention