BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIXENE 4-6MMX45CM GWT-GW, W/DBL GDS

    MDR report key: 3028025 · Received March 27, 2013

    Report

    Report Number
    1219977-2013-00023
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K071923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT COMPLAINED OF DISCOMFORT DURING DIALYSIS. A DEVICE EVALUATION CANNOT BE PERFORMED DUE TO THE FACT THE GRAFT REMAINS IMPLANTED AND NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE IN REGARDS TO THE COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ALONG WITH THE STERILIZATION RECORDS AND WERE FOUND TO HAVE MET ALL SPECIFICATIONS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON ANY ADDITIONAL INFORMATION THAT IS OBTAINED REGARDING THE COMPLAINT.

    Description of Event or Problem · 1

    TWENTY MINUTES POST CANNULATION (NEEDLE SIZE 16), PATIENT COMPLAINED OF DISCOMFORT IN UPPER GROIN. DIALYSIS DISCONTINUED. SWELLING NOTICED ON SITE IDENTIFIED AS ANASTOMOSIS AREA. PATIENT SENT TO (B)(6) FOR SCAN AND SURGICAL REVIEW. AREA REMAINS TENDER TO DATE. (B)(6) CONTACTED REGARDING SCAN RESULTS. THE PATIENT HAD SINGLE NEEDLE DIALYSIS. THE GRAFT REMAINS IMPLANTED, THE DIALYSIS WAS STOPPED AND FOUND THERE WAS NARROWING AT THE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125368 FLIXENE 4-6MMX45CM GWT-GW, W/DBL GDS DSY ATRIUM MEDICAL CORP. 25137 AK04517

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other PROLENE SUTURE - SIZE 5/0