BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR V-PATCH

    MDR report key: 8819953 · Received July 23, 2019

    Report

    Report Number
    3011175548-2019-00797
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    May 30, 2019
    Report Date
    July 23, 2019
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    UDI-DI
    00650862312003
    PMA / PMN Number
    K090909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MESH WAS RETURNED AND EVALUATED TO DETERMINE WHY THE OMEGA 3 FATTY ACID (O3FA) COATING WAS FLAKING OFF THE MESH. UPON RECEIPT THE V-PATCH MESH WAS REMOVED FROM THE PACKAGING AND INSPECTED. THE MESH SHOWED THAT THE O3FA COATING WAS FLAKING IN A FEW SPOTS AROUND THE CIRCUMFERENCE OF THE MESH. IT IS CLEAR THAT THE MESH HAD COME IN CONTACT WITH THE PATIENT AS THERE WAS NOTICEABLE BLOOD ON THE RETURNED MESH. THERE WERE ALSO MULTIPLE SUTURES STILL WITHIN THE MESH. THERE WAS A SPOT ALSO THAT APPEARS TO HAVE BEEN CUT WITH A SCALPEL OR SCISSOR. IN AN ATTEMPT TO HAVE MORE COATING FLAKE OFF THE MESH WAS ROLLED ONTO ITSELF DISTRESSING THE MESH MORE THAN IT WOULD UNDER NORMAL CIRCUMSTANCES. THE RESULT WAS THAT THE COATING STAYED INTACT. THE REMAINING COATING DID NOT FLAKE OFF. A REVIEW OF ALL LOT HISTORY RECORDS FOR THE C-QUR V-PATCH 31200 SMALL 1.7X1.7 (4.3CM) WAS CONDUCTED. ALL IN-PROCESS SPECIFICATIONS AND RELEASE CRITERIA WERE MET. NO DEVIATIONS OR NON-CONFORMANCES WERE REPORTED IN ANY OF THE MANUFACTURING AND STERILIZATION PROCESSES. ALL ACCEPTANCE CRITERIA WERE MET. THE INSTRUCTIONS FOR USE (IFU) STATES TO INSPECT THE MESH PRODUCT FOR ANY NOTICEABLE DAMAGE TO THE KNIT CONSTRUCTION OF THE MESH. DO NOT USE A C-QUR V-PATCH MESH THAT HAS ANY NOTICEABLE DAMAGE OR DISRUPTION TO THE KNIT CONSTRUCTION OF THE MESH AS THIS MAY LEAD TO DEVICE FAILURE. SUMMARY/CONCLUSION - BASED ON THE RESULTS OF THE INVESTIGATION THE ROOT CAUSE OF THE OMEGA 3 FATTY ACID (O3FA) COATING FLAKING OFF DURING HANDLING COULD NOT BE DETERMINED. PRIOR TO BEING SHIPPED FROM THE MANUFACTURING SITE THE C-QUR V-PATCH MESH MET ALL PRODUCT REQUIREMENTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HOSPITAL REPORTED COATING STARTED FLAKING OFF WITH MINIMAL MANIPULATION. MESH HAD TO BE REMOVED AND A NEW MESH WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611728 C-QUR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31200 435517 00650862312003

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR