BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR V-PATCH

    MDR report key: 4953313 · Received July 30, 2015

    Report

    Report Number
    1219977-2015-00207
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    July 28, 2015
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K080688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: UPON INVESTIGATION OF THE RETURNED MESH SAMPLE, IT WAS NOTICED THAT A SECTION OF STITCHING AROUND THE PERIMETER OF THE PATCH APPEARED TO BE ABSENT. THE MESH DID NOT LOOK MISHANDLED OR PHYSICALLY ADULTERATED (CUT/TORN) IN ANY WAY. THIS DEFECT IS REFERRED TO INTERNALLY AS "MISSING STITCHES" WHERE THERE IS A VOID IN THE STITCH PATTERN. "MISSING STITCHES" IS A SEWING DEFECT THAT CAN OCCUR DURING SETUP OF EACH SEWN PIECE AND IS 100% VISUALLY INSPECTED FOR IN MANUFACTURING. THE SETUP IS REPEATED PRIOR TO EACH V-PATCH SUB-ASSEMBLY BEING SEWN, AND AN ERROR IN THE SETUP OF ONE DOES NOT RELATE TO AN ERROR IN SETUP OF A PREVIOUS OR SUBSEQUENT SUB-ASSEMBLY. THIS IS LIKELY AN ISOLATED INCIDENT THAT WAS NOT IDENTIFIED DURING 100% VISUAL INSPECTION FOLLOWING THE SEWING PROCESS. A LOT HISTORY AND STERILIZATION RECORDS REVIEW WAS CONDUCTED FOR THE LOT OF V-PATCH ASSOCIATED WITH THIS COMPLAINT. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES NOTED WITH THE STITCHING OR CONSTRUCTION OF THE V-PATCH. THE PRODUCT WAS DOCUMENTED TO HAVE MET ALL LOT RELEASE CRITERIA, INCLUDING 100% VISUAL INSPECTION OF STITCHING, PRIOR TO LOT RELEASE. A REVIEW OF OUR COMPLAINTS SHOW THAT THERE ARE NO OTHER REPORTS OF THIS TYPE OF DEFECT.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THE PRODUCT WAS OPENED AND SOAKED, THEN TOUCHED THE PATIENT WHEN IT CAME APART. SURGEON SET THE MESH ASIDE AND USED ANOTHER MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496195 C-QUR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31202 217489

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention