Risk of life-threatening injuries or death if a metal object is brought into the magnetic field.
Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.
Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.
Patients may be exposed to serious infections.
Il Comitato di Valutazione del Rischio per la Farmacovigilanza
(Pharmacovigilance Risk Assessment Committee, PRAC) dell’Agenzia Europea
del Farmaco (European Medicine Agency, EMA) ha valutato che
l’idrossizina è associata a un rischio basso ma definito di
prolungamento dell’intervallo QT e di torsione di punta (alterazioni
dell’attività elettrica cardiaca che possono portare a un ritmo cardiaco
anomalo e all’arresto cardiaco).
Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.
The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.
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