BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 4801139 · Received May 26, 2015

    Report

    Report Number
    2242352-2015-00434
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. INTERNAL COMPLAINT NUMBER - TRACKWISE #: (B)(4).

    Additional Manufacturer Narrative · 1

    A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25111148, 25111702 AND 25112649 THE LAST THREE LOTS SHIPPED TO THE ACCOUNT A YEAR PRIOR TO THE AWARE DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AFTER AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 PATIENTS EXPERIENCED HEMATOMA WHICH WAS OBSERVED DURING FOLLOW FOLLOW-UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339258 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC C-VH-4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other