BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT MOBILE COMBO

    MDR report key: 1181031 · Received September 23, 2008

    Report

    Report Number
    1022819-2008-00212
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    March 26, 2007
    Report Date
    March 26, 2007
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Removal / Correction Number
    1022819-11/15/2007-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE HAD A HIGH ELECTROTHERAPY STIMULATION OUTPUT AT A LOW INTENSITY SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT MOBILE COMBO IPF, IMG, GZJ, GZI IPF CHATTANOOGA GROUP 2778

    Patients

    Seq Age Sex Outcome Treatment
    1