BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAGARD KNITTED

    MDR report key: 8216856 · Received January 4, 2019

    Report

    Report Number
    1640201-2019-00001
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    March 14, 2019
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION E2017024 : INTERVASCULAR SAS (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF MAQUET CARDIOVASCULAR, LLC (IMPORTER). (4118) NO INVESTIGATION COULD BE PERFORMED TO DATE SINCE THERE IS NO EVENT DESCRIPTION OR GRAFT IDENTIFICATION AVAILABLE. ADDITIONAL INFORMATION IS BEING SOUGHT. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DESPITE REPETITIVE EFFORTS, NO EVENT DESCRIPTION OR GRAFT IDENTIFICATION WERE PROVIDED. THEREFORE, NO INVESTIGATION COULD BE PERFORMED. THE DEVICE COMPLAINT CANNOT BE CONFIRMED. CORRECTED DATA: IT WAS REPORTED THAT THE INVOLVED GRAFT WAS OF TYPE UNKNOWN. HOWEVER, IN THE SAME COMPLAINT INTAKE FORM, IT WAS MENTIONED THAT THE DEVICE WAS AN HEMAGARD GRAFT. AS NO CONFIRMATION COULD BE OBTAINED, IT WAS CONSIDERED THAT THE INVOLVED DEVICE WAS AN HEMAGARD GRAFT: THE CORRESPONDING PRODUCT CODE FOR HEMAGARD IS DSY IN BLOCK D2.

    Description of Event or Problem · 0

    THE PATIENT'S VASCULAR GRAFT (TYPE UNKNOWN) HAD BECOME INFECTED AND THE SURGEON WONDERED IF THIS INFECTION WAS DUE TO A PRODUCT CHANGE. GETINGE WAS AWARE OF THIS FROM AN OFF-HAND CONVERSATION WITH THE HOSPITAL MATERIALS COORDINATOR. NO ADDITIONAL INFORMATION COULD BE RETRIEVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10414 HEMAGARD KNITTED VASCULAR POLYESTER GRAFT DSY INTERVASCULAR SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other