BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 10052512 · Received May 13, 2020

    Report

    Report Number
    1219930-2020-02008
    Event Type
    Injury
    Date Received
    May 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY: LONG-TERM OUTCOMES FOR DIFFERENT VAGINAL CUFF CLOSURE TECHNIQUES IN ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY: A RANDOMIZED CONTROLLED TRIAL SOURCE: 0301-2115/© 2016 PUBLISHED BY ELSEVIER IRELAND LTD. 210 (2017) 7¿12. (B)(4). 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 OCTOBER 2010¿APRIL 2012, POSTOPERATIVE FROM ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY VIA VAGINAL CUFF CLOSURE TECHNIQUE, THERE WERE 5 CASES OF BLEEDING, 3 CASES OF READMISSION, 1 CASE OF URINARY RETENTION AND 1 CASE OF INFECTION AT SHORT-TERM FOLLOW-UP. AT 1-YEAR FOLLOW-UP, THERE WERE 6 CASES OF VAGINAL BLEEDING, 4 CASES OF VAGINAL DISCHARGE OR INFECTION AND 2 CASES OF DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513951 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening