Category: Medical Devices
$12.7 Million Award In Polar Care Cold-Therapy Lawsuit
August 6, 2012 -- Engler has been awarded $7.5 million in punitive damages and $5.2 million in compensatory damages for skin necrosis, frostbite, and nerve damage caused by a Breg Polar Care cold therapy machine. She was prescribed the device...
Hospital Investigated for Experimental Bone Surgery
August 3, 2012 -- MassDevice is reporting that Pomona Valley Hospital Medical Center is being investigated by the California Health Department after a lawsuit was filed on behalf of a woman who was severely injured when her surgeon used two...
St. Jude Medical Recalls Eon, Eon Mini Implants
August 3, 2012 -- The Minnesota-based medical device company St. Jude Medical has updated a recall on the Eon and Eon Mini pain management system. There is a problem with a weld on some of the batteries, which can cause...
Antiseptic Wipes Recalled for Bacterial Contamination
August 2, 2012 -- Zee antiseptic swabs, Dukal antiseptic wipes, and Dukal BZK swabs are being voluntarily recalled after inspectors from the U.S. Food and Drug Administration (FDA) found some lots were contaminated with the bacteria Burkholderia cepacia. No injuries...
Heart Attacks More Common after Hip, Knee Replacement
July 23, 2012 -- The medical journal Archives of Internal Medicine has published a study finding that people aged 60 or older are significantly more likely to have a heart attack shortly after undergoing hip or knee replacement surgery. People...
Liptron 3000, Lipo-Ex Not Approved by FDA for Weight-Loss
July 20, 2012 -- The LipoTron 3000 (also referred to as the Lipo-Ex) is a medical device that is promoted as Radio Frequency (RF) Lipoplasty. Manufacturers and plastic surgeons claim that it uses high-frequency radio waves to heat subcutaneous fat,...
J&J Recalls Fentanyl Pain Patches for Crystallized Drug
July 20, 2012 -- Johnson & Johnson is recalling 53,000 Duragesic pain patches after finding a lot that “exhibited white spots, which were determined to be small fentanyl crystals.” The company has issued a Class III recall. There have been...
St. Jude Durata Defibrillator Leads May Have Riata Defect
July 19, 2012 -- A report submitted to the U.S. Food and Drug Administration (FDA) on April 18 suggests that the St. Jude Durata defibrillator lead could fail in the same was as the St. Jude Riata defibrillator lead. The...
FDA Investigating how Surveillance Documents Posted Online
July 19, 2012 -- Officials at the U.S. Food and Drug Administration (FDA) are trying to find out how 75,000 pages of confidential documents were accidentally posted on a public website. The documents were collected during a secret surveillance program...