BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 9700838 · Received February 12, 2020

    Report

    Report Number
    1219930-2020-00687
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    March 15, 2016
    Report Date
    February 12, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: A MULTICENTER STUDY COMPARING SURGICAL OUTCOMES AND ULTRASONOGRAPHIC EVALUATION OF SCARRING AFTER LAPAROSCOPIC MYOMECTOMY WITH CONVENTIONAL VERSUS BARBED SUTURES SOURCE: INTERNATIONAL JOURNAL OF GYNECOLOGY AND OBSTETRICS 134 (2016) 18¿21. RECEIVED 31 MAY 2015. RECEIVED IN REVISED FORM 23 OCTOBER 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED COMPARING THE CLINICAL OUTCOMES AFTER LAPAROSCOPIC MYOMECTOMY USING TRADITIONAL INTERRUPTED SUTURES (TIS) VERSUS CONTINUOUS BARBED SUTURE (CBS) FOR WOMEN WITH UTERINE MYOMAS AT THREE CENTERS BETWEEN JANUARY 1, 2009 AND JANUARY 31, 2015. SUTURING OF THE UTERINE WALL HAD BEEN PERFORMED INITIALLY USING TIS; CBS WERE USED FROM JANUARY 31, 2012. POST-OPERATIVE COMPLICATIONS IN THE CBS GROUP WERE 5 WITH PORT SITE HEMATOMA, 13 WITH HEMATOMA, 22 WITH FEVER AND 1 HAD BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163473 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention