BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH PS

    MDR report key: 25114252 · Received May 7, 2026

    Report

    Report Number
    2210968-2026-05015
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    December 24, 2025
    Report Date
    May 15, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: EUR J MED RES. 2025 DEC 24;31(1):145. HTTPS://DOI.ORG/10.1186/S40001-025-03735-5 PMID: 41437111; PMCID: PMC12849420.

    Description of Event or Problem · 0

    TITLE: CLINICAL APPLICATION OF LAPAROSCOPIC PECTOPEXY IN THE TREATMENT OF PELVIC ORGAN PROLAPSE: EFFICACY AND SAFETY. THIS SINGLE-CENTER RETROSPECTIVE STUDY AIMS TO EVALUATE THE EFFICACY AND SAFETY OF LAPAROSCOPIC PECTOPEXY IN THE TREATMENT OF FEMALE PELVIC ORGAN PROLAPSE (POP). BETWEEN JANUARY 2022 TO JUNE 2023, A TOTAL OF 40 PATIENTS WITH ANTERIOR AND/OR APICAL COMPARTMENT PROLAPSE WHO UNDERWENT LAPAROSCOPIC PECTOPEXY USING VICRYL 1¿0 STITCH TO CLOSE THE VAGINAL CUFF AND THE MID-SECTION OF MESH (GYNECARE GYNEMESH PS NONABSORBABLE PROLENE SOFT MESH, JOHNSON & JOHN SON, USA) WAS SUTURED TO VAGINAL APEX. REPORTED COMPLICATIONS ARE: VICRYL 1-0, GYNECARE GYNEMESH PS, PROLENE SOFT MESH, N=1 FEVER, TREATMENT: UNSPECIFIED TREATMENT, N=1 URINARY RETENTION, TREATMENT: UNDERGONE INDWELLING URINARY CATHETER AGAIN, N=2 CHRONIC PELVIC PAIN, TREATMENT: NOT REPORTED, N=1 MESH EXPOSURE, TREATMENT: NOT REPORTED, N=1 OBJECTIVE RECURRENCE 12 MONTHS PRESENTING ANTERIOR PROLAPSE (POP-Q STAGE), TREATMENT: UNDERWENT OPERATIONAL INTERVENTION AGAIN, N=1 OBJECTIVE RECURRENCE 12 MONTHS PRESENTING POSTERIOR PROLAPSE (POP-Q STAGE), TREATMENT: UNDERWENT OPERATIONAL INTERVENTION AGAIN, N=1 OBJECTIVE RECURRENCE 12 MONTHS PRESENTING ANTERIOR PROLAPSE AND POSTERIOR PROLAPSE (POP-Q STAGE), TREATMENT: UNDERWENT OPERATIONAL INTERVENTION AGAIN. IN CONCLUSION, LAPAROSCOPIC PECTOPEXY IS A POTENTIAL SURGICAL PROCEDURE FOR POP, ESPECIALLY FOR THOSE WITH ANTERIOR AND APICAL COMPARTMENTS PROLAPSE. LONG-TERM OUTCOMES OF LAPAROSCOPIC PECTOPEXY STILL NEEDS FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115619 GYNECARE GYNEMESH PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1