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