BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 9028100 · Received September 13, 2019

    Report

    Report Number
    2242352-2019-01022
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 18, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25147416, 25147360; THE LAST 2 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WERE NO NCMR'S RECORDED IN THE LOT HISTORY. CORRECTED SECTIONS: B3 - DATE OF EVENT REMOVED, B5 - UPDATED EVENT DESCRIPTION.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED DURING PATIENT FOLLOW UP IN THE MD'S OFFICE, BLISTERING WAS NOTED ALONG THE PATH OF THE EVH TUNNEL. STATED THE VEIN WAS VERY SUPERFICIAL AND THAT IT IS POSSIBLE THE SPOT CAUTERY ON THE VASOVIEW HEMOPRO 2 MAY HAVE CAUSED SOME "BURNS". THE PATIENT IS ON WOUND CARE TREATMENTS TO HEAL THE AREA.

    Additional Manufacturer Narrative · 1

    (B)(64). 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. DEVICE SCRAPPED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED DURING PATIENT FOLLOW UP IN THE MD'S OFFICE, BLISTERING WAS NOTED ALONG THE PATH OF THE EVH TUNNEL. HE DID NOT RECALL THE DATE OF THE PROCEDURE. STATED IT WAS "LAST WEEK, I DON'T KNOW WHICH DAY". STATED THE VEIN WAS VERY SUPERFICIAL AND THAT IT IS POSSIBLE THE SPOT CAUTERY ON THE VH4000 MAY HAVE CAUSED SOME "BURNS". THE PATIENT IS ON WOUND CARE TREATMENTS TO HEAL THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812163 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention