BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR EDGE MESH

    MDR report key: 6701284 · Received July 11, 2017

    Report

    Report Number
    3011175548-2017-00021
    Event Type
    Injury
    Date Received
    July 11, 2017
    Date of Event
    February 15, 2008
    Report Date
    July 11, 2017
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS AND PRODUCT COMPLAINT DETAILS ATRIUM CAN FIND NO FAULT WITH THE PRODUCT. THIS LOT OF MESH PASSED ALL QUALITY AND PERFORMANCE REQUIREMENT. CLINICAL EVALUATION: ABDOMINAL ADHESIONS ARE BANDS OF FIBROUS TISSUE THAT CAN FORM BETWEEN ABDOMINAL TISSUES AND ORGANS AFTER ABDOMINAL SURGERY OR INFLAMMATORY PROCESSES. NORMALLY, INTERNAL TISSUES AND ORGANS HAVE SLIPPERY SURFACES, PREVENTING THEM FROM STICKING TOGETHER AS THE BODY MOVES. HOWEVER, ADHESIONS CAUSE TISSUES AND ORGANS IN THE ABDOMINAL CAVITY TO STICK TOGETHER. ABDOMINAL ADHESIONS CAN BECOME LARGER AND TIGHTER AS TIME PASSES, SOMETIMES CAUSING PROBLEMS YEARS AFTER SURGERY. CAREFUL ATTENTION TO PROPER FIXATION TECHNIQUES AND PLACEMENT OF THE MESH PRODUCT SHOULD BE TAKEN TO HELP PREVENT EXCESSIVE TENSION OR DISRUPTION BETWEEN THE MESH MATERIAL AND CONNECTIVE TISSUE. PLACING SURGICAL MESH IN CONTACT WITH THE INTESTINES AND/OR IMPROPER SURGICAL FIXATION CAN INCREASE INCIDENCE OF ADHESIONS. A SMALL-BOWEL OBSTRUCTION (SBO) IS CAUSED BY A VARIETY OF PATHOLOGIC PROCESSES. THE LEADING CAUSE OF SBO IS POSTOPERATIVE ADHESIONS. OBSTRUCTION CAN BE CHARACTERIZED AS EITHER PARTIAL OR COMPLETE VERSUS SIMPLE OR STRANGULATED. ABDOMINAL PAIN THAT LASTS AS LONG AS SEVERAL DAYS, IS PROGRESSIVE IN NATURE, AND IS ACCOMPANIED BY ABDOMINAL DISTENTION MAY BE TYPICAL OF A MORE SEVERE OBSTRUCTION. A STRANGULATED OBSTRUCTION IS A SURGICAL EMERGENCY. IN PATIENTS WITH A COMPLETE SBO, THE RISK OF STRANGULATION IS HIGH AND EARLY SURGICAL INTERVENTION IS WARRANTED. PROLONGED PAIN CAN BE DEFINED AS PAIN PERSISTING FOR MORE THAN THREE MONTHS AFTER SURGERY AND IT IS A COMPLICATION OF MANY COMMON PROCEDURES INCLUDING HERNIA REPAIR. SURGICAL TECHNIQUE CAN INFLUENCE THE DEVELOPMENT OF CHRONIC POST-SURGICAL PAIN AND TECHNIQUES TO MINIMIZE NERVE INJURY SHOULD BE USED WHENEVER POSSIBLE. THE INSTRUCTIONS FOR USE (IFU) STATES COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY SURGICAL MESH INCLUDE, BUT ARE NOT LIMITED TO, INFLAMMATION, INFECTION, SEROMA, PAIN, 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. THE IFU ALSO STATES THAT ADEQUATE MESH FIXATION IS REQUIRED TO MINIMIZE POST-OPERATIVE COMPLICATIONS AND RECURRENCE. THE FIXATION TECHNIQUE, METHOD, AND PRODUCTS USED (INCLUDING SUTURES, TACKS, STAPLES OR OTHER MEANS) IS LEFT TO THE DISCRETION OF THE SURGEON TO OPTIMIZE CLINICAL OUTCOMES.

    Description of Event or Problem · 1

    RECEIVED REPORT OF FOLLOWING MESH IMPLANT FOR HERNIA REPAIR, PATIENT ALLEGEDLY HAD INTESTINAL BLOCKAGE, ULCER IN HER SMALL INTESTINE, PAIN AFTER SURGERY, AND NOW HAS AN UMBILICAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482005 C-QUR EDGE MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORP. 31228 10298927

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention