BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR V-PATCH

    MDR report key: 7495112 · Received May 8, 2018

    Report

    Report Number
    3011175548-2018-00449
    Event Type
    Injury
    Date Received
    May 8, 2018
    Report Date
    May 8, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K080688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, THE INFECTION AND RECURRENCE RATES ASSOCIATED WITH THE C-QUR V-PATCH MESH IS ACCEPTABLY LOW.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED: SURGICAL OUTCOMES OF A NOVEL OMEGA-3 FATTY ACID COATED POLYPROPYLENE MESH IN VENTRAL HERNIA REPAIRS. THE ARTICLE EXAMINED EVIDENCE SURROUNDING THE C-QUR V-PATCH REGARDING ITS RATED OF RECURRENCE AND INFECTION. PER THE ARTICLE, ADVERSE EVENTS INCLUDED INFECTION AND RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338730 C-QUR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention