BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-QUR MESH (4X6)

    MDR report key: 2695280 · Received August 8, 2012

    Report

    Report Number
    1219977-2012-00018
    Event Type
    Other
    Date Received
    August 8, 2012
    Date of Event
    November 11, 2011
    Report Date
    August 8, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO PRODUCT WAS RETURNED FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED. FOLLOWING INVESTIGATION, OUR CONCLUSION IS THAT THE PROBABLE ROOT CAUSE IS UNKNOWN DUE TO NOT ENOUGH INFORMATION AVAILABLE TO MAKE A DETERMINATION. THE DEVICE HISTORY RECORDS FOR THE BATCH WERE REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH OUR STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION AND THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH.

    Description of Event or Problem · 1

    FDA MEDWATCH (B)(4), RECEIVED 07/27/2012 ON (REDACTED) 2011, PATIENT WAS IMPLANTED FOR INCISIONAL HERNIA REPAIR WITH AN 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 (REDACTED) 2011 TO REMOVE THE 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. AS PER THE SURGEON'S STATEMENT AND SURGICAL REPORT THE MESH NEVER ALLOWED HEALING, MESH FRACTURED AND WAS VERY POORLY INCORPORATED. PREVIOUSLY OTHERWISE HEALTHY TISSUE WAS REMOVED, INCLUDING PREVIOUSLY HEALTHY MUSCLE TISSUE WAS REMOVED BECAUSE OF DAMAGE DONE BY ATRIUM C-QUR. BECAUSE OF THE 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. PATIENT IS NOW HAD HAS BEEN ON HEAVY PAIN MEDICATION SINCE (REDACTED) 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 C-QUR MESH (4X6) FTL ATRIUM MEDICAL CORP. 31528 10740287

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R