BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB

    MDR report key: 9946869 · Received April 9, 2020

    Report

    Report Number
    1219930-2020-01649
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    September 13, 2016
    Report Date
    April 9, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    UDI-DI
    10884521043329
    PMA / PMN Number
    K963253
    Removal / Correction Number
    R201911-05
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: V-LOCTM 180 SUTURE IN TOTAL LAPAROSCOPIC HYSTERECTOMY: A RETROSPECTIVE STUDY COMPARING POLYSORB TO BARBED SUTURE USED FOR VAGINAL CUFF CLOSURE SOURCE: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 207 (2016) 18¿22. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY OF 490 CONSECUTIVE WOMEN WHO UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY PERFORMED BETWEEN JANUARY 2013 AND SEPTEMBER 2015 APPLYING IDENTICAL PROCEDURE TECHNIQUE WITH CUFF CLOSURE. FOR THE FIRST 184 WOMEN, GROUP 1, AN ABSORBABLE SUTURE WAS APPLIED IN TRANSVAGINAL CUFF CLOSURE. FOR THE FOLLOWING 306 WOMEN, GROUP 2, A BARBED SUTURE WAS USED WITH LAPAROSCOPIC INTRACORPOREAL SUTURING. AS A RESULT, IN BOTH GROUPS, VAGINAL CUFF HEALING WAS WELL WITH NO DEHISCENCE. VAGINAL CUFF GRANULOMATOUS OCCURRED MORE OFTEN IN WOMEN IN GROUP 1 (8/184, 4.34%) THAN WOMEN IN GROUP 2 (6/306, 1.96%) SIX MONTHS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409389 POLYSORB SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN CL-914 10884521043329

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention