BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MOSAIC

    MDR report key: 5141869 · Received October 9, 2015

    Report

    Report Number
    1219977-2015-00296
    Event Type
    Injury
    Date Received
    October 9, 2015
    Date of Event
    September 30, 2015
    Report Date
    October 1, 2015
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K121070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    C-QUR MOSAIC MESH WAS REVIEWED FOR LOT HISTORY AND STERILIZATION RECORDS. THE FINISHED GOOD AND SUBASSEMBLY LOTS PASSED ALL IN-PROCESS INSPECTIONS AND TESTING INCLUDING BUT NOT LIMITED TO FOURIER-TRANSFORM INFRARED SPECTROSCOPY AND PRE & POST STERILE POUCH PEEL. ALL RAW MATERIALS MET ALL INCOMING TESTING AND INSPECTIONS. THE STERILIZATION RECORDS SHOW THAT ALL RESULTS PASSED. WARNING 5 OF THE MOSAIC IFU STATES THE FOLLOWING: "IT IS IMPORTANT TO ORIENT C-QUR MOSAIC MESH CORRECTLY FOR PROPER FUNCTION. THE SMOOTH SIDE OF THE MESH SHOULD BE POSITIONED FACING THE BOWEL OR OTHER VISCERAL SURFACES WHERE MINIMAL TISSUE ATTACHMENT IS DESIRED."

    Additional Manufacturer Narrative · 1

    MARKETING AND REGULATORY WERE CONSULTED ABOUT THE FIRST PRODUCT COMPLAINT THAT IT IS DIFFICULT TO DETERMINE LAPAROSCOPICALLY WHICH SIDE OF THE C-QUR MOSAIC MESH SHOULD BE PLACED AGAINST THE BOWEL. A DECISION WAS MADE TO ADD INSTRUCTIONS TO THE IFU TO ORIENT THE SMOOTH SIDE OF THE MESH AGAINST THE BOWEL WHEN PLACED LAPAROSCOPICALLY. THE MOSAIC IFU IS BEING UPDATED TO STATE THE FOLLOWING: "IT IS IMPORTANT TO ORIENT C-QUR MOSAIC MESH CORRECTLY FOR PROPER FUNCTION. THE SMOOTH SIDE OF THE MESH SHOULD BE POSITIONED FACING THE BOWEL OR OTHER VISCERAL SURFACES WHERE MINIMAL TISSUE ATTACHMENT IS DESIRED." THIS IFU WOULD HAVE BEEN WITH THE LOT REPORTED IN THIS FILE AS IFU WAS CHANGED. THE IFU IS PENDING FDA REVIEW OF 510(K) FOR LABELING CHANGES AND WAS SUBMITTED 25-MAY-2015 - 510(K) K151386. A REVIEW OF THE COMPLAINTS DATABASE REVEALED (B)(4) OTHER REPORT RELATED TO AN INCIDENT DESCRIPTION OF THIS TYPE. CLINICAL EVALUATION: DIFFICULT DETECTING WHICH MESH SIDE IS USED ON A PATIENT HAS A RISK OF PLACING THE ROUGH SIDE AND NOT THE SMOOTH SIDE TOWARDS THE VISCERAL SURFACES AND THIS PLACEMENT MAY INDUCE ADHESIONS. ADHESIONS ARE FIBROUS BANDS THAT FORM BETWEEN TISSUES AND ORGANS. ADHESIONS FORM AS A NATURAL PART OF THE BODY'S HEALING PROCESS AFTER SURGERY IN THE SAME WAY THAT A SCAR FORMS.

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC REPAIR OF A VENTRAL HERNIA, MOSAIC COATED MESH (9CM ROUND) WAS INSERTED THROUGH THE TROCAR. LAPAROSCOPICALLY, IT WAS DIFFICULT TO DETERMINE WHICH SIDE OF THE MESH WAS COATED. THE SURGEON REMOVED THE MESH FROM THE BODY AND TRIED AGAIN WHILE REMEMBERING HOW HE INSERTED THE MESH TO DETERMINE WHICH SIDE IS WHICH ON THE SCREEN. THE PATIENT HAD NO COMPLICATIONS BECAUSE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671620 C-QUR MOSAIC MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31105 401313

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention