BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 22487735 · Received July 11, 2025

    Report

    Report Number
    1219930-2025-02959
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    December 16, 2024
    Report Date
    July 11, 2025
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VEREECK, S., ALEXANDER, J., CAREY, M., ROSAMILIA, A. OUTCOME OF LAPAROSCOPIC VERSUS VAGINAL HIGH UTEROSACRAL LIGAMENT VAULT SUSPENSION AT THE TIME OF HYSTERECTOMY ,2025. INTERNATIONAL UROGYNECOLOGY JOURNAL, 36; HTTPS://DOI.ORG/10.1007/S00192-024-06033-6. PAGES 695¿702 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2019 AND 2021, A RETROSPECTIVE COHORT STUDY ANALYZED THE OUTCOME OF HYSTERECTOMY WITH HIGH UTEROSACRAL LIGAMENT SUSPENSION (HUSLS) FOR SYMPTOMATIC PELVIC ORGAN PROLAPSE (POP) VIA VAGINAL OR LAPAROSCOPIC APPROACH. A TOTAL OF 111 WOMEN MET THE INCLUSION CRITERIA. TWELVE WERE EXCLUDED, LEAVING 99 FOR ANALYSIS. HUSLS WAS PERFORMED VAGINALLY IN 47 AND LAPAROSCOPICALLY IN 52 WOMEN. ABSORBABLE SUTURE WAS USED FOR LAPAROSCOPIC HUSLS AND LAPAROSCOPIC CLOSURE OF THE VAGINAL VAULT. POSTOPERATIVE ADVERSE EVENTS INCLUDED RECURRENT POP. INTERVENTIONS MENTIONED INCLUDED REOPERATION OR PESSARY DEVICE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073530 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN SURGICAL UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention