Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
Significant probability of serious health consequences if more than the prescribed dose is dispensed, including: drowsiness causing trauma; increased anxiety; and risk of accidental injury to self or others.
Common side effects of bupropion include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. Risk of allergic reactions are possible and could be life threatening.
Reports of B. cepacia infections in patients.
Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.
Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system.
Drug products, including FDA-approved products, containing polyethylene glycol castor oil have been associated with severe and sometimes fatal hypersensitivity reactions.
Use could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Use of product found to contained undeclared Sildenafil could result in death. The groups affected include men with diabetes, high blood pressure, high cholesterol, or heart disease.
Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.