BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCKER SWITCH PENCIL

    MDR report key: 8260690 · Received January 17, 2019

    Report

    Report Number
    MW5083213
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    January 14, 2019
    Report Date
    January 15, 2019
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROTECTED CAUTERY TIP CAUSED SKIN BURNS, PROXIMAL TO TIP ON BACK "PROTECTED" AREA OF TIP. PROGRESSIVE MEDICAL, INC., (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52268 ROCKER SWITCH PENCIL ELECTROSURGICAL, CUTTING, COAGULATION ACCESSORIES GEI COVIDIEN E2515H 121680
    52269 NON-STICK CAUTERY TIP ELECTROSURGICAL CUTTING COAGULATION ACCESSORIE GEI UNK 1803009

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention