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Page 21 - Adverse Event Reporting Program News Today : Breaking News, Live Updates & Top Stories | Vimarsana

FDA Recalls 60,000 Abbott Pacemakers Due to Defect

Abbott’s SBP model pacemakers, sold under the Assurity and Endurity names, are being recalled because of the risk of electrical shorts.

Abbott Recalls Assurity and Endurity Pacemakers

   • A loss of device pacing.    • Telemetry failure or errors in information    • Early and fast battery drain    • Less time between the first battery depletion warning (elective replacement indicator or ERI) and the device’s end of service (EOS) If the device is unable to deliver pacing, patients may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness or discomfort. Additionally, shorter battery life and device life may lead to an additional pacemaker replacement procedure sooner than expected. Finally, if the system does not relay accurate information via telemetry, medical providers may not know to provide treatment. Abbott s patient management guidelines including:

Public Notification: Burn 7 contains hidden drug ingredient

[12-17-2020] The Food and Drug Administration is advising consumers not to purchase or use Burn 7, a product promoted and sold for weight loss on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that Burn 7 purchased from eBay.com contains phenolphthalein. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it may increase the risk of cancer. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA s MedWatch Safety Information and Adverse Event Reporting Program:

Public Notification: Li Da Daidaihua Plus contains hidden drug ingredient

[12-17-2020] The Food and Drug Administration is advising consumers not to purchase or use Li Da Daidaihua Plus, a product promoted and sold for weight loss on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that Li Da Daidaihua Plus purchased from eBay.com contains phenolphthalein. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it may increase the risk of cancer. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA s MedWatch Safety Information and Adverse Event Reporting Program:

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