Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material
UPDATED 09/19/2017 Updating after extensive review of data and information.
Italiano
UPDATED 09/19/2017 Updating after extensive review of data and information.
Tue, 19 Sep 2017 00:00:00 -0400
L’Agenzia Europea dei Medicinali (EMA) ha concluso che non esistono evidenze chiare e coerenti di una differenza nell'incidenza dello sviluppo degli inibitori tra le due classi di medicinali a base di fattore VIII: quelli derivati dal plasma e quelli ottenuti con la tecnologia del DNA ricombinante.
Separation could result in required intervention to prevent permanent impairment/damage.
May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017
If not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.
If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.
If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.
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