Events

Retiro De Equipo (Recall) de Brand name: || NIM¿ EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 || NIM¿ EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 || [All products are packaged one unit per box.]

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Xomed, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    30357
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0310-05
  • Fecha de inicio del evento
    2004-10-29
  • Fecha de publicación del evento
    2004-12-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35726
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stimulator, Nerve - Product Code ETN
  • Causa
    The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. in one case in germany it was reported that the patient had soreness of the throat and was discharged after four days. in the next case the patient had a tracheal wound. it was not clear what caused the wound.

Device

Brand name: || NIM¿ EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29...
  • Modelo / Serial
    Product Code: 77 ETN  Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
  • Descripción del producto
    Brand name: || NIM¿ EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 || NIM¿ EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 || [All products are packaged one unit per box.]
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Dirección del fabricante
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA