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Category Archives: Neurology
Medtronic DBS NDE Kits Class 1 Recall
Medtronic: Class 1 Recall – Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit AUDIENCE: Neurology, Nursing, Risk Manager, Surgery ISSUE: Medtronic sent an Urgent Medical Device Correction letter to all affected customers notifying them of the potential … Continue reading
Posted in FDA 2013, FDA Recall, Neurology, Nursing, Risk Manager, Surgery
Tagged Activa Dystonia HDE, Class 1 Recall, Class I Recall, DBS, Deep Brain Stimulation Lead Kit, FDA recall, Kits, Medtronic, Medtronic DBS NDE Kits Class 1 Recall, NDE, Neurology, Nursing, Recall, Risk Manager, Surgery
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Valproate Anti-Seizure Products Drug Safety Communication
Valproate Anti-Seizure Products: Drug Safety Communication – Contraindicated for Pregnant Women for Prevention of Migraine Headaches Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics AUDIENCE: Health Professional, Neurology, … Continue reading
Posted in FDA 2013, FDA Safety Communication, Healthcare Professionals, Neurology, Patients, Pharmacy
Tagged anti-seizure medication, Anti-Seizure Products, divalproex sodium, Drug Safety Communication, Health Professional, Neurology, Patient, Pharmacy, pregnant women, Valproate, Valproate Anti-Seizure Products Drug Safety Communication, valproate sodium, valproic acid
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Potiga Ezogabine Drug Safety Communication
Potiga (Ezogabine): Drug Safety Communication – Linked To Retinal Abnormalities And Blue Skin Discoloration AUDIENCE: Health Professional, Neurology, Patient ISSUE: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized … Continue reading
Posted in FDA 2013, FDA Safety Communication, Healthcare Professionals, Neurology, Patients
Tagged Blue Skin Discoloration, drug risks, Drug Safety Communication, Ezogabine, FDA notice, Health Professional, Neurology, Patient, Potiga, Potiga Ezogabine Drug Safety Communication, Retinal Abnormalities, Safety Communication
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Ad-Tech Macro Micro Subdural Electrodes Recall
Ad-Tech Macro Micro Subdural Electrodes Audience: Risk Manager, Biomedical Engineering, Neurosurgery ISSUE: FDA and Ad-Tech notified healthcare professionals of a Class 1 recall due to concern the microelectrodes are defective and may cause injury to the brain. These devices are … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Recall, Neurology, Risk Manager, Surgery
Tagged Ad-Tech Macro, Ad-Tech Macro Micro Subdural Electrodes Recall, Biomedical Engineering, Class 1 Recall, Class I Recall, drug risks, FDA recall, Micro Subdural Electrodes, Neurosurgery, Recall, Risk Manager, Surgery
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Vycor Viewsite Brain Access System VBAS Class 1 Recall
Vycor Viewsite Brain Access System (VBAS): Class 1 Recall – Unidentified Fiber Found on Device AUDIENCE: Neurology, Surgery, Risk Managers ISSUE: Vycor Medical recalled its VBAS because an unidentified black fiber was found on the device. This product … Continue reading
Posted in FDA 2013, FDA Recall, Neurology, Risk Manager, Surgery
Tagged Brain Access System, Class 1 Recall, Class I Recall, FDA recall, Neurology, Recall, Risk Managers, Surgery, VBAS, Vycor Viewsite, Vycor Viewsite Brain Access System VBAS Class 1 Recall
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Medtronic Drug Infusion Pumps Recall
Medtronic Drug Infusion Pumps: Recall – Intermittent or Permanent Pump Motor Stall SynchroMed II ImplantableSynchroMed EL Implantable Audience: Risk Manager, Physical Medicine, Neurosurgery ISSUE: FDA and Medtronic notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump … Continue reading
Posted in FDA 2012, FDA Recall, Neurology, Physical Medicine, Risk Manager
Tagged Drug Infusion Pumps, Medtronic, Medtronic Drug Infusion Pumps Recall, Neurosurgery, Physical Medicine, Recall, Risk Manager
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Xyrem sodium oxybate Drug Safety Communication
Xyrem (sodium oxybate): Drug Safety Communication – Warning Against Use With Alcohol or Drugs Causing Respiratory Depression AUDIENCE: Neurology, Internal Medicine, Patient ISSUE: FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or … Continue reading
Posted in FDA 2012, FDA Safety Communication, Internal Medicine, Neurology, Patients
Tagged Drug Safety Communication, Internal Medicine, Neurology, Patient, sodium oxybate, Xyrem, Xyrem sodium oxybate Drug Safety Communication
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New England Compounding Center Fungal Meningitis Outbreak
New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak Latest Update from The FDA AUDIENCE: Surgery, Anesthesia, Neurology, Healthcare Professionals ISSUE: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial … Continue reading
Posted in Anesthesiology, FDA 2012, FDA Warning, Healthcare Professionals, Neurology, Surgery
Tagged Anesthesia, CDC, drug risks, FDA news, FDA warning, Fungal Meningitis Outbreak, Healthcare Professionals, injectable steroid, methylprednisolone acetate, Neurology, New England Compounding Center, New England Compounding Center Fungal Meningitis Outbreak, Surgery
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Mirapex pramipexole Drug Safety Communication
Mirapex (pramipexole): Drug Safety Communication – Ongoing Safety Review, Possible Risk of Heart Failure AUDIENCE: Neurology ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk … Continue reading
Posted in FDA 2012, FDA Safety Communication, Neurology
Tagged drug risks, Drug Safety Communication, FDA notice, Mirapex, Mirapex pramipexole Drug Safety Communication, Neurology, pramipexole
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Stryker Wingspan Stent System Safety Communication
Stryker Wingspan Stent System: Safety Communication – Narrowed Indications for Use AUDIENCE: Neurology, Surgery, Patients ISSUE: The FDA is informing health care providers and patients that the indications for use and labeling for the Wingspan stent have changed … Continue reading
Posted in FDA 2012, FDA Safety Communication, Neurology, Patients, Surgery
Tagged Drug Safety Communication, FDA Recalls, FDA warning, Safety Communication, safety label changes, Stryker Wingspan Stent System
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