Events

Alerte De Sécurité sur Bravo pH capsule delivery devices for Bravo pH Monitoring System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medtronic.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-04-22
  • Date de publication de l'événement
    2016-04-22
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160422.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: medtronic bravo ph capsule delivery devices for bravo ph monitoring system medical device manufacturer, medtronic, has issued a medical device safety alert concerning all lots of its bravo ph capsule delivery devices for bravo ph monitoring system [fgs-0312 (5-pack) and fgs-0313 (1-pack)] according to the manufacturer, it has received three reports from customers related to patients having allergic reactions to the nickel content in the stainless steel trocar needle that attaches the bravo capsule to the esophageal mucosa. allergic reactions can include hives, itching or oral numbness. there have been no reports of serious injury related to this safety notice. the manufacturer 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. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 april 2016.

Device

Bravo pH capsule delivery devices for Bravo pH Monitoring System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Bravo pH capsule delivery devices for Bravo pH Monitoring System
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH