Events

Rappel de Bravo pH capsule delivery device

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 Covidien LLC.

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
    73882
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1619-2016
  • Date de mise en oeuvre de l'événement
    2016-04-15
  • Date de publication de l'événement
    2016-05-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145297
  • 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
    Electrode, ph, stomach - Product Code FFT
  • Cause
    Potential of an allergic reaction in a patient with nickel sensitivity.
  • Action
    The firm, Medtronic, sent an "URGENT: Medical Device Recall" letter dated 4/15/2016 to its Customers via Federal Express. The letter describes the product, problem and actions to be taken.The customer was instructed to promptly forward the information from the letter to recipients, if you have distributed any of the affected devices; and complete and return the Acknowledgement and Receipt Form by email to: Quality Compliance MITGFCA@Covidien.com or Fax to: (203) 492-7719. Medtronic is adding the following statement to the Bravo¿ pH monitoring system User Manual and product package insert so that physicians are aware of the nickel content and the potential of an allergic reaction in a patient with nickel sensitivity. "The Bravo capsule contains a trocar needle that is made of stainless steel. Use caution in patients with known sensitivities or allergies to the metals that are contained including chromium, nickel, copper, cobalt and iron. The Bravo¿ pH test lasts from 48-96 hours." If you have any questions, please contact Technical Service at 1-800-448-3644, option 3.

Device

Bravo pH capsule delivery device
  • Modèle / numéro de série
    All lot numbers
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.
  • Description du dispositif
    Given Imaging Bravo¿ pH capsule delivery device, 5-pack. || In-Vitro Diagnostic for pH monitoring of gastric reflux || Item Number: FGS-0312 || The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Adresse du fabricant
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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