BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CQUR TACSHIELD

    MDR report key: 2963664 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00227
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, (B)(4) WAS ISSUED FOR A 4" X 6" C-QUR TACSHIELD MESH (PRODUCT CODE (B)(4), LOT #10734260018) THAT WAS USED FOR AN UMBILICAL HERNIA REPAIR AT (B)(6) HOSPITAL IN (B)(6) ON (B)(6) 2012. THE AUSTRALIAN INCIDENT REPORT STATES THAT "THE REPAIR WAS MADE IN A TENSION-FREE MANNER WITH A 10X15CM INTRAPERITONEAL COMPOSITE MESH (C-QUR TACSHIELD) WHICH WAS SUTURED TO THE DEFECT MARGINS AND ANCHORED WITH TACKS AT THE PERIMETER." IN ADDITION IT WAS NOTED THAT THE "PATIENT DEVELOPED DISCHARGE POST OP" AND THERE WAS "SEROMA EVIDENT AND SEROUS FLUID ASPIRATED." THE REPORT GOES ON TO SAY THAT THE RECORDS PROVIDED STATE THAT THE PT "PRESENTED 2 WEEKS LATER WITH GRANULOMA TISSUE AND SIGNS OF INFECTION." THE MEDICAL RECORDS PROVIDED STATE THAT THE PT WAS "PRESCRIBED A/B'S BY GP (2 COURSES) WITH NO EFFECT. MESH EXPLANTED 2 WEEKS LATER." THE C-QUR TACSHIELD MESH WAS EXPLANTED ON (B)(6) 2012 AND A PORTION WAS RETURNED TO ATRIUM FOR EVALUATION. THE SAMPLE WAS NOT RETURNED IN FORMALIN FIXATIVE AND WAS EVALUATED BY ATRIUM R+D ON (B)(6) 2012. .

    Description of Event or Problem · 1

    PT HAD A UMBILICAL HERNIA REPAIR. AT OPERATION, A COMPLEX COLLECTION OF HERNIAS WERE ENCOUNTERED AT THE UMBILICUS. THERE WERE TRUE UMBILICAL DEFECTS TO THE LEFT AND RIGHT OF THE UMBILICAL STALK WITH PROTRUSION OF EXTRAPERITONEAL FAT. IN ADDITION, THERE WERE 2 SUPRAUMBILICAL HERNIAS OF THE LINEA ALBA, AGAIN WITH (LARGER) HERNIATION OF EXTRAPERITONEAL FAT. ALL DEFECTS WERE DEFINED AND THEN UNITED TO CREATE ONE DEFECT OF 5CM IN DIAMETER. THE REPAIR WAS MADE IN A TENSION-FREE MANNER WITH A 10X15CM INTRAPERITONEAL COMPOSITE MESH (CQUR TACSHIELD) WHICH WAS SUTURED TO THE DEFECT MARGINS AND ANCHORED WITH TACKS AT THE PERIMETER. PT DEVELOPED DISCHARGE POST OP. SEROMA EVIDENT AND SEROUS FLUID ASPIRATED. PRESENTED TWO WEEKS LATER WITH GRANULOMA TISSUE AND SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974 CQUR TACSHIELD FTL ATRIUM MEDICAL CORP 31628 10734260

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention