BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MOSAIC MESH

    MDR report key: 7158046 · Received January 2, 2018

    Report

    Report Number
    3011175548-2018-00002
    Event Type
    Injury
    Date Received
    January 2, 2018
    Date of Event
    September 1, 2017
    Report Date
    January 2, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K121070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A FULL REVIEW OF ALL MANUFACTURING LOT HISTORY RECORDS WAS PERFORMED AND NO DEFICIENCIES WERE NOTED DURING THE REVIEW. ALL THE RECORDS INDICATE THAT THE PRODUCT IN QUESTION MET THE PRODUCT REQUIREMENTS AND WAS COMPLETED CORRECTLY WITHOUT DEVIATIONS. CLINICAL EVALUATION: INDICATIONS FOR USE: ATRIUM C-QUR MOSAIC MESH PRODUCTS ARE 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. DERMATITIS IS ONE OF THE MOST COMMON CAUSES OF RASHES. RASHES OCCUR WHEN THE SKIN COMES INTO DIRECT CONTACT WITH A FOREIGN SUBSTANCE THAT CAUSES AN ADVERSE REACTION, LEADING TO A RASH. THE RESULTING RASH MAY BE ITCHY, RED, OR INFLAMED. POSSIBLE CAUSES OF CONTACT DERMATITIS INCLUDE COSMETICS, DETERGENTS, DYES, CHEMICALS AND PLANTS. THE INSTRUCTIONS FOR USE (IFU)1 STATES COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY SURGICAL MESH INCLUDE, BUT ARE NOT LIMITED TO, INFLAMMATION, INFECTION, SEROMA, HEMATOMA, FISTULA FORMATION OR 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

    RECEIVED A REPORT THAT A PATIENT HAD DEVELOPED A RASH POST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384 C-QUR MOSAIC MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL 31128 475182

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention