People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.
Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Acute lead poisoning may cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Long term exposure can lead to permanent damage to the central nervous system. Posted 11/08/2016
Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.
The most recent post-approval study results assessing post-market performance is available.
New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.
Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.
The FDA is concerned that health care providers may be unaware of the risks associated with these devices.
PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.
User may not be able to connect electrodes to Welch Allyn AED model 10 defibrillator, which may result in a delay in delivering the electrical therapy.
New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.
In some cases full battery drainage can occur within a day to a few weeks after patient receives ERI alert. If battery runs out, ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.
The effects of Burkholderia cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.
Excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
FDA requiring a Boxed Warning about the risk of HBV reactivation to be added to drug labels, directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment.
Bacteria and/or particulate matter present in an unsterile solution could pass through to a compounded prepared solution, which could lead to adverse health consequences.
Adverse events reported to the agency, including seizures in infants and children who were given these products.
Potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse health consequences, including death.