BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 3231517 · Received July 15, 2013

    Report

    Report Number
    1219977-2013-00091
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED AND NO DEVICE MALFUNCTIONS WERE DISCOVERED. A REVIEW OF THE COMPLAINTS DATABASE WAS PERFORMED AND WE HAVE NOT RECEIVED ANY OTHER REPORTS ON THIS DEVICE LOT NUMBER. ATRIUM MEDICAL CONSULTED WITH A CLINICIAN ON THIS EVENT. HE STATED THAT POSTOPERATIVE SMALL BOWEL OBSTRUCTION IS A KNOWN COMPLICATION AFTER ANY INTRAPERITONEAL OPERATION. WE ALSO INQUIRED IF THE MESH COULD HAVE BEEN THE CAUSE OF THE BOWEL OBSTRUCTION AND HE DID FEEL THE C-QUR MESH WAS THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    LAPAROSCOPIC INCISIONAL HERNIA MULTIPLE DEFECTS ALONG MIDLINE. SURGEON REPORTED BOWEL OBSTRUCTION IMMEDIATELY AFTER IMPLANTATION. VENTRAL HERNIA MIDLINE SIZE OF HERNIA IS >10CM, LAPAROSCOPIC HERNIA REPAIR, MESH POSITION IS INTRAPERITONEAL (INSIDE THE ABDOMINAL CAVITY), PERMANENT SUTURES, ABSORBABLE TACKS. POSTOPERATIVE COMPLICATIONS: ENTEROTOMY/BOWEL INJURY, ACUTE BOWEL OBSTRUCTION. OCCURRED DURING RECOVERY. TWO WEEKS SYMPTOMATIC. NO INTERVENTION NEEDED AND MESH WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326729 C-QUR MESH FTL ATRIUM MEDICAL CORP. 31537 10813994

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other