Preventing Medical Errors: What to Do about Unretrieved Device Fragments

December 31, 2007

A recent FDA article in the journal Nursing2007 alerts healthcare personnel about the potential dangers posed by fragments of medical devices that are left in a patient's body. FDA receives more than a thousand reports each year of device fragments ...

Preventing Medical Errors: Avoiding Hazards from Using Cleaners and Disinfectants on Electronic Medical Equipment

December 31, 2007

FDA, CDC, EPA and OSHA have issued a Public Health Notification on how to avoid hazards when using liquid cleaners and disinfectants on electronic medical equipment. The Notification covers a wide range of equipment, including infusion pumps, ventil...

Recalls and Safety Alerts: Ongoing Safety Review of Maxipime

December 31, 2007

FDA has notified healthcare professionals about a recent study that raises the possibility of an increased risk of death among patients taking cefepime, which is marketed as Maxipime. The study, reported in the journal, The Lancet Infectious Disease...

Recalls and Safety Alerts: Recall of Thoratec Implantable Ventricular Assist Devices

December 31, 2007

The Thoratec Corporation is recalling some of its implantable ventricular assist devices (IVADs) because air leaks could develop in the driveline when the device is used outside the patient's body. Five injuries and one death have been reported as a...

Recalls and Safety Alerts: Warning on Fentora Buccal Tablets

December 31, 2007

FDA is warning healthcare professionals about deaths and patient injuries from Fentora (fentanyl buccal tablets) a drug used to treat breakthrough cancer pain. Some of these events occurred because the drug was prescribed for patients who should...

Recalls and Safety Alerts: Marketing of Trasylol Suspended

December 31, 2007

Bayer Pharmaceuticals has suspended the marketing of Trasylol (aprotinin) which is used to reduce perioperative blood loss during cardiac surgery with cardiopulmonary bypass. Preliminary results of a Canadian study indicate that while patients given...

Recalls and Safety Alerts: Certain Welch Allyn Defibrillators Recalled

December 31, 2007

The device company, Welch Allyn, is recalling some of its AED 10 automatic external defibrillators. A defective capacitor in some of these devices may cause them to malfunction, and in some cases this may prevent the defibrillator from analyzing a p...

Recalls and Safety Alerts: Sudden Hearing Loss from Erectile Dysfunction Drugs

December 31, 2007

FDA has received about 30 reports of sudden hearing loss in patients taking a class of erectile dysfunction drugs called PDE5 inhibitors. This class of drugs includes Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). The problem was...

Recalls and Safety Alerts: Serious Skin and Hypersensitivity Reactions with Provigil

December 31, 2007

Cephalon has notified healthcare professionals about new safety information for Provigil (modafinil). Provigil is used to reduce excessive sleepiness in adult patients with narcolepsy and other sleep disorders. Provigil is not approved for any indi...

Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular (also known as Shangai Chaojimengnan)

December 31, 2007

Products marketed as dietary supplements contain undeclared active ingredients of products used to treat erectile dysfunction.

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