BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2212676 · Received August 10, 2011

    Report

    Report Number
    2242352-2011-01113
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF EVENT TO ENSURE THAT THERE IS NO COMPROMISE TO QUALITY. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NON CONFORMANCE ISSUE(S) WITH THIS PRODUCTION LOT. (B)(4).

    Description of Event or Problem · 1

    A PHONE CALL FROM A MARKETING REPRESENTATIVE REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMO PRO 2 BURNED THROUGH THE PATIENT'S SKIN. THIS WAS REPORTED IN TWO DIFFERENT CASES. REPLACEMENT UNITS WERE USED TO COMPLETE THE PROCEDURES. THERE IS NO REPORT ON PATIENT'S CONDITION. HOSPITAL, CONTACT INFORMATION, LOT NUMBERS AND EVENT DATES ARE UNKNOWN. THE PRODUCTS ARE NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VVH-4000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI