Events

Rappel 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.]

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Xomed, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    30357
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0310-05
  • Date de mise en oeuvre de l'événement
    2004-10-29
  • Date de publication de l'événement
    2004-12-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35726
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Stimulator, Nerve - Product Code ETN
  • Cause
    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...
  • Modèle / numéro de série
    Product Code: 77 ETN  Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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