BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM 30CM HEMASHIELD PLAT WDV

    MDR report key: 4142565 · Received September 30, 2014

    Report

    Report Number
    2242352-2014-01033
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    PMA / PMN Number
    K954848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THERE ARE NO OTHER SIMILAR COMPLAINTS REPORTED AGAINST THIS BATCH. INTERNAL COMPLAINT NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING REPLACEMENT OF THE ASCENDING AORTA WITH 28MM 30CM HEMASHIELD PLAT WDV AND AFTER SURGERY, THE AMOUNT OF DRAINAGE DID NOT DECREASE. THE CURRENT AMOUNT OF DRAINAGE WAS STILL ABOUT 1000ML/DAY. NO TRANSFUSION WAS CONDUCTED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL EFFECTS WERE REPORTED. THE PATIENT CONDITION IS CURRENTLY BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608024 28MM 30CM HEMASHIELD PLAT WDV VASCULAR GRAFTS MAL MAQUET CARDIOVASCULAR, LLC 25091139

    Patients

    Seq Age Sex Outcome Treatment
    1 Other