Events

Safety Alert for Bravo pH capsule delivery devices for Bravo pH Monitoring System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-04-22
  • Event Date Posted
    2016-04-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160422.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Bravo pH capsule delivery devices for Bravo pH Monitoring System
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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