BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR V-PATCH

    MDR report key: 8259479 · Received January 17, 2019

    Report

    Report Number
    3011175548-2019-00087
    Event Type
    Injury
    Date Received
    January 17, 2019
    Report Date
    January 17, 2019
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. IT IS NOT KNOWN WHAT RELATIONSHIP THE C-QUR V-PATCH HAS TO THE REPORTED ADVERSE EVENTS. PER THE STUDY, RECURRENCE RATES ASSOCIATED WITH THE NOVEL C-QUR V-PATCH MESH IS ACCEPTABLY LOW; HOWEVER, INFECTION RATES APPEAR TO BE HIGHER WHEN COMPARED TO COMPARABLE PRODUCTS FOR USE IN VENTRAL HERNIA REPAIRS.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED "INFECTION AND RECURRENCE RATES OF THE C-QUR V-PATCH IN VENTRAL HERNIA REPAIRS". THE ARTICLE INVESTIGATED THE INFECTION AND RECURRENCE RATES OF THIS NOVEL MESH PRODUCT AND COMPARE THIS WITH PUBLISHED DATA OF COMPARABLE MESH DESIGNS. PER THE ARTICLE ADVERSE EVENTS INCLUDED RECURRENCE AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52202 C-QUR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention