BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NICOLET BIOMEDICAL

    MDR report key: 107862 · Received July 1, 1997

    Report

    Report Number
    107862
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    March 18, 1997
    Report Date
    March 28, 1997
    Manufacturer
    NICOLET BIOMEDICAL
    Product Code
    GXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTRODE BROKE OFF IN PT DURING EVOKE POTENTIALS PROCEDURE. ELECTRODE NEEDLE BROKE OFF IN THE LATERAL, LEFT KNEE. SURGERY WAS PROLONGED 40 MINS. WHILE M.D. REMOVED NEEDLE. NEEDLE WAS REMOVED FROM THE VASTUS LATERALIS FASCIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLET BIOMEDICAL SUBDERMAL NEEDLE ELECTRODE W/ DIN GXZ NICOLET BIOMEDICAL 019-404500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention