BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTFE VASCULAR SOFT GRAFTS

    MDR report key: 2241168 · Received August 17, 2011

    Report

    Report Number
    2242352-2011-01143
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FDA METHOD: THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    WHILE VISITING MERCY HEALTH CENTER ON (B)(6), 2011, AND MEETING WITH DR. (B)(6), IT WAS REPORTED THAT HE HAD EXPERIENCED A CASE OF AN EXXCEL SOFT TEARING. ADD'L DETAILS OF THIS EVENT HAVE NOT BEEN REPORTED AT THIS TIME, BUT ARE BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTFE VASCULAR SOFT GRAFTS VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI