BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIERRA SUMMIT

    MDR report key: 15904337 · Received December 2, 2022

    Report

    Report Number
    15904337
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 16, 2022
    Report Date
    November 28, 2022
    Manufacturer
    CADWELL INDUSTRIES, INC.
    Product Code
    IKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STIMULATOR FAILED TO STIMULATE DURING NERVE CONDUCTION STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349002 SIERRA SUMMIT ELECTROMYOGRAPH, DIAGNOSTIC IKN CADWELL INDUSTRIES, INC. 190274-200

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Female