BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM C-QUR MESH

    MDR report key: 4330606 · Received December 9, 2014

    Report

    Report Number
    MW5039581
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 15, 2013
    Report Date
    December 9, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2012, I WENT TO THE HOSPITAL RECEIVE AN UMBILICAL HERNIA REPAIR. THE INITIAL SURGEON REPAIRED THE HERNIA WITH THE ATRIUM C-QUR MESH PATCH. IN (B)(6) 2013, I EXPERIENCED SEVERE PAIN IN THE AREA OF THE HERNIA REPAIR. I WENT TO THE DOCTOR AND HE ORDERED X-RAYS OF MY ABDOMEN, THERE, HE NOTICED AN UNDEFINABLE MASS IN THE AREA OF THE HERNIA REPAIR. THE SURGEON SCHEDULED SURGERY TO CONFIRM WHAT THE MASS WAS. DURING THE SURGERY, HE REMOVED A ROUND HARD OBJECT WHICH WAS LATER IDENTIFIED AS THE ATRIUM C-QUR MESH. THE SURGEON DETERMINED THE MESH FAILED TO INCORPORATE INTO MY SURROUNDING TISSUE DUE TO EXTENDED DELAY CAUSED BY THE PROPERTIES AND DESIGN OF THE BARRIER, RESULTING IN THE REMOVAL OF THE ATRIUM C-QUR MESH. THE HOSPITAL PATHOLOGY LAB DETERMINED THE MESH WAS REJECTED BECAUSE OF FOREIGN BODY RESPONSE. I SUFFERED CHRONIC PAIN AND INFLAMMATION AFTER THE SURGERY AND TO THE PRESENT DAY. I WAS HOSPITALIZED FOR 10 DAYS AFTER THE REMOVAL OF THE ATRIUM C-QUR MESH, MISSED MANY DAYS OF WORK, AND STILL SUFFER FROM A DECREASED QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793179 ATRIUM C-QUR MESH ATRIUM C-QUR MESH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| L| R| S