BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MOSAIC

    MDR report key: 6142182 · Received December 2, 2016

    Report

    Report Number
    3011175548-2016-00012
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K121070
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING LOT HISTORY AND STERILIZATION RECORDS WAS CONDUCTED. ALL IN-PROCESS SPECIFICATIONS AND RELEASE CRITERIA WERE MET, INCLUDING TESTING FOR SUTURE RETENTION (COURSE AND WALE) AND BALL BURST CONDUCTED ON THE MESH AT INCOMING. FOURIER-TRANSFORM INFRARED SPECTROSCOPY TESTING, IN-PROCESS VISUAL INSPECTION OF THE CURED COATED MESH/PANELS, COATING DENSITY OF THE CURED COATED PANELS, AND SEAL STRENGTH TESTING ON BOTH THE PRE-AND-POST-STERILE ATRIUM-APPLIED PACKAGING SEALS WERE ALSO PERFORMED, WITH ALL REQUIREMENTS BEING MET. EXAMINATION OF THE RETURNED SAMPLE (IDENTICAL CODE NUMBER AND LOT NUMBER AS IMPLANTED SAMPLE) DID NOT REVEAL ANY ABNORMALITIES OR DEFECTS IN THE COATING. THE OMEGA 3 FATTY ACID COATING WAS INTACT UPON REMOVAL OF THE C-QUR MOSAIC MESH FROM ITS PACKAGING AND AFTER EXPOSURE TO SALINE AND AFTER CUTTING/TRIMMING THE MESH. BLOOMING OF THE COATING WAS NOTED; HOWEVER, IT IS ACCEPTABLE PER THE INSPECTION CRITERIA. THE SAMPLE, FROM THE SAME LOT, RETURNED MET ALL INSPECTION REQUIREMENTS AND WOULD HAVE BEEN ACCEPTABLE FOR USE. CLINICAL EVALUATION: C-QUR¿ MOSAIC MESH HAS A COATING DERIVED FROM BIOLOGICAL OIL COMPOSED OF FATTY ACIDS, LIPIDS AND GLYCERIDES (BAO BIO-ABSORBABLE OIL COATING). IT HAS A COATING THAT IS ABSORBABLE BY THE BODY AND IF IN THE EVENT IT DOES FLAKE OR COME OFF DURING A PROCEDURE IT WOULD CAUSE NO HARM TO THE PATIENT, THE MESH WOULD THEN BECOME THE EQUIVALENT OF BARE MESH. A PHYSICIAN MAY DETERMINE A PRODUCT IS NOT SUITABLE FOR AN INTENDED PROCEDURE AT ANY TIME AND FOR ANY REASON HE DEEMS SIGNIFICANT ENOUGH TO COMPROMISE PATIENT OUTCOMES. IN THE EVENT THE PHYSICIAN HAS A CHANGE OF PLAN DURING A PROCEDURE IT WOULD RESULT IN A DELAY IN TREATMENT. THE INSTRUCTIONS FOR USE STATE UNDER ADVERSE REACTION, THAT COMPLICATIONS MAY OCCUR WITH THE USE OF ANY SURGICAL MESH INCLUDE, BUT ARE NOT LIMITED TO, MECHANICAL DISRUPTION OF THE TISSUE AND/OR MESH MATERIAL, POSSIBLE ADHESIONS WHEN PLACED IN DIRECT CONTACT WITH THE VISCERA (INTESTINES) AND ORGANS.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON THE CONCLUSION OF THE INVESTIGATION INTO THIS EVENT.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT A SURGEON HAD PLACED MESH INTO ABDOMEN AND FLAKING OF OMEGA 3 FATTY ACIDS WAS NOTICED AFTER TACKING AND SECURING INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792753 C-QUR MOSAIC MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31105 401313

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention ETHICON SECURESTRAP