BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM C-QUR 4" X 6"

    MDR report key: 2650980 · Received July 5, 2012

    Report

    Report Number
    MW5026078
    Event Type
    Injury
    Date Received
    July 5, 2012
    Date of Event
    September 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT WAS IMPLANTED FOR INCISIONAL HERNIA REPAIR WITH THE ATRIUM C-QUR POLYPROPYLENE SURGICAL MESH WITH OMEGA 3 FATTY ACID BIO-ABSORBABLE COATING. AFTER MUCH PAIN AND SWELLING AROUND INCISION SITE FOR 9 WEEKS, ADDITIONAL SURGERY TOOK PLACE ON (B)(6) 2011 TO REMOVE ATRIUM C-QUR MESH. FATTY ACID COATING CAME OFF IN A FEW WEEKS AND LEFT BARE POLYPROPYLENE SURGICAL MESH IN CONTACT WITH OTHERWISE HEALTHY TISSUE AND CAUSED A SIGNIFICANT FOREIGN BODY REACTION AND INFLAMMATION AND A "COTTAGE CHEESE LIKE SUBSTANCE", NOT INFECTION, WHICH SURROUNDED THE MESH. MESH NEVER ALLOWED HEALING, AS PER SURGEON'S STATEMENT AND SURGICAL REPORT. MESH FRACTURED, AS PER SURGEONS STATEMENT. MESH WAS "VERY, VERY POORLY INCORPORATED" AS PER SURGEONS STATEMENT AND SURGICAL REPORT. PREVIOUSLY OTHERWISE HEALTHY TISSUE WAS REMOVED, INCLUDING PREVIOUSLY HEALTHY MUSCLE TISSUE WAS REMOVED BECAUSE OF DAMAGE DONE BY ATRIUM C-QUR. BECAUSE OF -PREVIOUSLY HEALTHY- TISSUE REMOVAL SURROUNDING THE ATRIUM C-QUR, SURGEON WAS LEFT WITH ONLY OPTION TO PERFORM A RETRO RECTUS REPAIR IMPLANTING 15X15 ETHICON PROLENE MESH. SUBSEQUENT LIFE THREATENING INFECTION, PROLONGED HOSPITALIZATION, THEN 6 WEEKS OF HOME IV INFUSION OF VANCOMYCIN, ADDITIONAL 5 WEEKS OF ORAL VANCOMYCIN. THIRD SURGERY IS NOW REQUIRED TO REMOVE ETHICON PROLENE MESH. PT IS NOW AND HAS BEEN ON HEAVY PAIN MEDICATION SINCE (B)(6) 2011, HAS ADDITIONAL NUMEROUS HEALTH PROBLEMS WHICH AROSE AFTER IMPLANT OF ATRIUM C-QUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM C-QUR 4" X 6" HERNIA MESH FTL ATRIUM MEDICAL CORPORATION 10740287017
    2 PROLENE MESH 15X15 HERNIA MESH FTL ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other