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FDA MedWatch Safety Alerts

Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Posted: January 14, 2017, 5:00 am
Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
Posted: January 13, 2017, 4:00 pm
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
Posted: January 12, 2017, 2:00 pm
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
Posted: January 11, 2017, 10:30 pm
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
Posted: January 11, 2017, 3:50 pm
These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.
Posted: January 9, 2017, 5:00 am
IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. Do not rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions.
Posted: December 23, 2016, 2:35 pm
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
Posted: December 20, 2016, 3:00 pm
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
Posted: December 16, 2016, 5:01 pm
Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain.
Posted: December 14, 2016, 5:01 pm
FDA approved label updates to describe additional studies reviewed.
Posted: December 12, 2016, 8:05 pm
Excess material may separate from catheter during use and enter patient’s bloodstream, resulting in serious adverse health consequences such as blood clots, embolism of the excess material to vital organs, or death.
Posted: December 9, 2016, 8:30 pm
Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Posted: December 1, 2016, 1:40 pm
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Posted: December 1, 2016, 1:15 pm
DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Posted: November 26, 2016, 3:00 pm
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
Posted: November 25, 2016, 5:00 am
Can lead to serious adverse health consequences including embolism, stroke, or death.
Posted: November 22, 2016, 7:50 pm
Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening.
Posted: November 21, 2016, 8:00 pm
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Posted: November 21, 2016, 5:30 pm
People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
Posted: November 18, 2016, 7:00 pm