BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE E-Z CLEAN MEGAFINE

    MDR report key: 9030440 · Received September 13, 2019

    Report

    Report Number
    MW5089782
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    September 9, 2019
    Report Date
    September 11, 2019
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ELECTROCAUTERY TIP BY MEGADYNE (REF# 0118A, LOT# 193480) WAS BEING USED AND THE TIP CREATED A FLAME DURING USE. A SIMILAR PROBLEM WITH TIP INSULATION "BUBBLING" HAS ALSO HAPPENED IN THE PAST WITH THE SAME PRODUCT (LOT# 187318). NO PT HARM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819186 MEGADYNE E-Z CLEAN MEGAFINE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC. 0118A 193480
    819187 MEGADYNE E-Z CLEAN MEGAFINE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC. 0118A 187318

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention