BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 7497860 · Received May 9, 2018

    Report

    Report Number
    3011175548-2018-00453
    Event Type
    Injury
    Date Received
    May 9, 2018
    Report Date
    May 9, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT CODE, LOT NUMBER OR SAMPLE WAS PROVIDED PER THE STUDY, LAPAROSCOPIC HERNIA REPAIR USING C-QUR FOR INCISIONAL AND INGUINAL HERNIAS IS A SAFE AND EASY PROCEDURE. [(B)(4)].

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED: LAPAROSCOPIC HERNIOPLASTY USING OMEGA-3 COATING MESH. THE ARTICLE PRESENTED A PROSPECTIVE OBSERVATIONAL STUDY OF LAPAROSCOPIC HERNIOPLASTY USING C-QUR. PER THE ARTICLE, ADVERSE EVENTS INCLUDED PAIN, SWELLING, RECURRENCE AND SKIN NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341937 C-QUR MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention