BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CQUR TACSHIELD

    MDR report key: 2903458 · Received January 4, 2013

    Report

    Report Number
    1219977-2012-00038
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 6, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING ANALYSIS: THE EXACT CAUSE OF THE INFECTION CANNOT BE DETERMINED. THE PROCEDURE WAS AN OPEN PROCEDURE AND IS THE LIKELY CAUSE OF THE INFECTION. THE LOT HISTORY RECORD WAS REVIEWED AND CONFIRMED THE PRODUCT WAS STERILIZED PER ATRIUM MEDICAL'S STANDARD PROCESS. ATRIUM MEDICAL HAS COMPLETED A RE-VALIDATION OF THE STERILIZATION CYCLE (FRACTIONAL CYCLE), (B)(4) THAT CONFIRMS THE STERILIZATION CYCLE ENSURES A MINIMUM STERILITY ASSURANCE LEVEL (SAL) OF (B)(4). SUMMARY/CONCLUSION: IT IS UNLIKELY THAT THE MESH CAUSED THE INFECTION. OPEN PROCEDURES ARE MORE SUSCEPTIBLE TO INFECTION AS DISCUSSED IN THE ATTACHED MEMO. ALSO, PER THE PHYSICIAN'S STATEMENT, THE PATIENT HAD A BLOOD FLOW OBSTRUCTION WHICH COULD POTENTIALLY CAUSE THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A (B)(6) THIN FEMALE PATIENT UNDERWENT ABDOMINAL INCISIONAL HERNIA REPAIR THROUGH AN ANTERIOR APPROACH FOLLOWING SMALL-INTESTINAL PERFORATION. INTRAOPERATIVELY C-QUR TACSHIELD (CATALOG/SN: 31233/(B)(4)) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURED TO THE PERITONEUM WITH ABSORBA TACK AND PDS SUTURES TO REPAIR THE HERNIA ORIFICE OF 15 CM IN THE RIGHT LOWER QUADRANT OF THE ABDOMEN. THE ANTIBIOTIC WAS CONCOMITANTLY ADMINISTERED INTRAVENOUSLY ALONG WITH THE HERNIA REPAIR. THE OPERATIVE SITE NOTED BECAME RED IN THE IMMEDIATE POSTOPERATIVE PERIOD SINCE THE SKIN OF THE SITE BECAME THIN. IN (B)(6) 2012 (AN EXACT DATE IS UNKNOWN), ON POSTOPERATIVE DAYS (B)(6), THE PATIENT PRESENTED WITH REDNESS AND PAIN OF THE OPERATIVE SITE. ON THE SAME DAY, DRAINAGE WAS PERFORMED IN THE PATIENT AND THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL. ON AN UNKNOWN DATE IN 2012, TWO TO THREE DAYS AFTER ADMISSION, THE TACSHIELD WAS REMOVED. INTRAOPERATIVELY, THE LESION OF THE INTESTINAL TRACT ADHERED TO THE TACSHIELD WAS NOTED. INTESTINAL JUICE WAS DRAINED THROUGH A DRAINAGE TUBE. THE PATIENT WILL HAVE BEEN DELIVERED PARENTERAL NUTRIENTS THROUGH A TUBE UNTIL RE-SURGERY. THE PATIENT HAS BEEN FOLLOWED AND WILL BE REQUIRED TO BE IN THE HOSPITAL FOR SEVERAL MONTHS. THE PHYSICIAN ALSO INDICATED THE PATIENT HAD A BLOOD FLOW OBSTRUCTION WHICH COULD POTENTIALLY CAUSE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4963 CQUR TACSHIELD FTL ATRIUM MEDICAL CORP. 31233 10819845

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R