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Summary Information for: FreeStyle Navigator® Continuous Glucose Monitoring System - P050020

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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PDF format only. Topics: Glucose Monitoring

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Federal Register: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar (Notice of public seminar).

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health and Office of Regulatory Affairs, in cooperation with AdvaMed’s Medical Technology Learning Institute, is announcing a series of three seminars on FDA medical device…

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Patients Are Asking: Caution Giving Children Cough and Cold Medicines

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
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FDA is cautioning parents and caregivers about giving their children cough and cold medicines.

FDA strongly recommends that cough and cold medicines NOT be given to children younger than 2 years old because serious and potentially life-threateni…

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Preventing Medical Errors: Mixups between Insulin U-100 and U-500

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
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The Institute for Safe Medication Practices (ISMP) recently described an increase in reports about mixups between insulin U-100 and insulin U-500. These errors could result in dangerous hyperglycemia or hypoglycemia. Mistakes have occurred when pre…

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Preventing Medical Errors: Remembering to Re-Activate a Patients?s Defibrillator

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
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A recent FDA article in the journal “Nursing2008″ describes the case of a patient who died, possibly of ventricular fibrillation, following elective surgery. This happened because after the procedure, his implantable cardioverter defibrillator (ICD)…

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Recalls and Safety Alerts: New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
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The prescribing information for the Ortho Evra Contraceptive Transdermal Patch is being updated with results of a new study on the risk of venous thromboembolism. This study found that women aged 15-44 who used the birth control patch were at higher…

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Recalls and Safety Alerts: Early Communication on Adverse Events from Botox and Myobloc

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
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FDA has issued an early communication about serious adverse events, including respiratory failure and death, from Botox and Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B). These events were related to how the product w…

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Recalls and Safety Alerts: New Safety Warnings about Chantix

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
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FDA is alerting healthcare professionals about new safety warnings for Chantix (varenicline), a drug used to help people stop smoking.

Chantix has been linked to serious neuropsychiatric problems, including changes in behavior, agitation, depres…

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Recalls and Safety Alerts: Fentanyl (Duragesic) Patches Recalled

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
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Several brands of fentanyl transdermal patches are being recalled because they may have defects that could allow the fentanyl gel to leak out of the patch. If the gel touches patient’s or caregiver’s skin, it could cause respiratory depression and p…

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New Medical Products: Decellularized Allograft Heart Valve Approved

Published in March 31st, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
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FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed. It is called the CryoValve SynerGraft Pulmonary Heart Valve, and is manufactured by CryoLife, Inc.

Allograft valves are recove…

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