BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR MOSAIC

    MDR report key: 6431407 · Received March 24, 2017

    Report

    Report Number
    3011175548-2017-00010
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    March 14, 2017
    Report Date
    March 24, 2017
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    UDI-DI
    00650862311280
    PMA / PMN Number
    K121070
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ALL IN-PROCESS SPECIFICATIONS AND RELEASE CRITERIA WERE MET, INCLUDING PRE-AND-POST-STERILE SEAL STRENGTH TESTING ON THE PACKAGING, FOURIER-TRANSFORM INFRARED SPECTROSCOPY AND COATING DENSITY TESTING ON THE CURED COATED C-QUR MOSAIC PANEL, AND VISUAL INSPECTION OF THE COATING OF THE CUT SAMPLE. BALL BURST, SUTURE RETENTION (COURSE AND WALE DIRECTIONS), AND FTIR TESTING WERE CONDUCTED ON THE POLYPROPYLENE MESH MATERIAL AT INCOMING AND ALL ACCEPTANCE CRITERIA WAS ALSO MET. CLINICAL EVALUATION: C-QUR MOSAIC MESH IS A STERILE, KNITTED POLYPROPYLENE MONOFILAMENT MESH MATERIAL WITH A NON-CONTINUOUS COATING DERIVED FROM BIOLOGICAL OIL COMPOSED OF FATTY ACIDS, LIPIDS AND GLYCERIDES (BAO BIOABSORBABLE OIL COATING). THIS PRODUCT IS INTENDED FOR USE IN SOFT TISSUE DEFICIENCIES INCLUDING HERNIA REPAIR, CHEST WALL RECONSTRUCTION, TRAUMATIC OR SURGICAL WOUNDS AND OTHER FASCIAL SURGICAL INTERVENTION PROCEDURES REQUIRING REINFORCEMENT WITH A SUPPORTIVE MATERIAL. THE BAO COATING IS ABSORBABLE BY THE BODY. IF IN THE EVENT THE COATING 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. 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.

    Description of Event or Problem · 1

    THE SURGEON HAD COMPLETED THE IMPLANTATION OF THE MESH AND HE NOTICED THE MESH COATING ON HIS GLOVES. THERE WAS NO DAMAGE NOTED TO THE MESH WHEN REMOVING IT FROM THE PACKAGING. STAFF REPORTED THAT APPROXIMATELY HALF OF THE COATING CAME OFF BUT IT WAS IN PATCHES AND NOT IN LOCALIZED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214604 C-QUR MOSAIC MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31128 401722 00650862311280

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention