Medical Device Claims Archives - Page 11 of 20

Medtronic Issues Recall Of Its 6 French Sherpa NX Active Guide Catheters Due To Separation And Fragmentation Issue

December 12, 2019

Medtronic announced on October 8, 2019 that it was recalling its 6 French Sherpa NX Active Guide Catheters due to a separation and fragmentation issue. The 6 French Sherpa NX Active Guide Catheter is used to access veins and arteries inside and outside of the heart (coronary and peripheral vascular [...]

FDA Issues Draft Guidance Regarding Breast Implants

November 26, 2019

On October 24, 2019, the FDA issued “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication” containing recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The FDA stated[...]

Are Filshie Clips Causing Allergic Reactions?

October 29, 2019

We continue to receive many inquiries from women who have had Filshie clips implanted as a form of sterilization who complain that they suffered various allergic reactions to the materials contained in Filshie clips, including but not limited to fatigue, pain, and what has been deemed as post implan[...]

New York Appellate Court Overturns Medical Malpractice Defense Verdict Due To Impermissible Habit Testimony

October 28, 2019

The Supreme Court of the State of New York, Appellate Division, Second Judicial Department (“New York Appellate Court”), in its decision filed on October 16, 2019, stated: “The issue on this appeal is whether a physician performing a surgical procedure who has no written record nor[...]

34 Vaping Deaths In 24 U.S. States, 1,604 Vaping Lung Injuries (As Of October 22, 2019)

October 27, 2019

As of October 22, 2019, 1,604 cases of e-cigarette, or vaping, product use associated lung injury (EVALI) have been reported to CDC from 49 states (all except Alaska), the District of Columbia, and one U.S. territory. Thirty-four vaping deaths have been confirmed in 24 states: Alabama, California (3[...]

Is Your Doctor Being Paid By A Drug Company Or Medical Device Company?

October 19, 2019

ProPublica reported on October 17, 2019 in an article entitled “We Found Over 700 Doctors Who Were Paid More Than a Million Dollars by Drug and Medical Device Companies” that “More than 2,500 physicians have received at least half a million dollars apiece from drugmakers and medica[...]

CDC Updates Number Of Vaping Lung Disease Cases, Now Over 1,000

October 5, 2019

On October 3, 2019, the CDC announced an update regarding the number of confirmed and probable lung injury cases and vaping deaths associated with e-cigarette product use in the United States. The CDC announced that as of October 1, 2019, there were 1,080 confirmed and probable lung injury cases ass[...]

Alaris™ Pump Modules Model 8100 Recalls

September 22, 2019

In a recall notification sent on April 15, 2019, Becton, Dickinson and Company (“BD”) informed clinicians that the bezel assemblies in certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 were manufactured with a specific type of plastic material. BD condu[...]

FDA Sends JUUL Labs, Inc. Warning Letter Regarding Its Marketing Of Electronic Cigarettes

September 9, 2019

Juul Labs, Inc. (“JUUL”) is an electronic cigarette company that makes the Juul e-cigarette that packages nicotine salts from leaf tobacco into one-time use cartridges. JUULpods contain cigarette-like strength nicotine levels via proprietary nicotine salts formula. Smart temperature-regu[...]

Oklahoma Hospital Used Contaminated Gastroscopes On 998 Patients

September 8, 2019

According to a MAUDE Adverse Event Report filed during this past summer by Hota Corporation Pentax Tokyo Office (“Pentax Medical”), “Pentax medical became aware of a report on 26-jun-2019 stating that the forward water jet channel on three customer-owned pentax medical gastroscopes[...]

Allergan Textured Breast Implants Recalled At FDA’s Request

July 26, 2019

On July 24, 2019, the FDA issued a safety communication requesting Allergan to voluntarily recall certain breast implants and tissue expanders to protect patients from risks associated with certain textured breast implants. The macro-textured implants, like the BIOCELL textured implants manufactured[...]

Kaiser Health News Reports On FDA’s “Hidden” Database Of Malfunctions Of Medical Devices

July 2, 2019

Kaiser Health News reported on June 27, 2019 that its investigation found that “[medical] device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database [alternative summary reporting database], bypassing the public FDA databas[...]

« 1 … 6 7 8 9 10 11 12 13 14 15 16 … 20 »

Category: Medical Device Claims