medical device

FDA Launches Home-Use Medical Device Pilot Program

Every year, more than 7 million patients receive home health medical care under the direction of their medical providers. Many such cases require the use of medical devices in the home to treat or maintain a wide variety of conditions. The devices are put to use by the patient directly, or with the help of a caregiver or family member.
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Defective Wheelchair Lifts Sold Even After Recall

Defective medical devices are not limited to those implanted in a patient’s body. Patients who must use canes, wheelchairs, or other devices to get around are susceptible to a whole array of device warnings and risks that other Americans are not.
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New Breast Scanning Device Could Alleviate Risks of Mammography

The benefits and risks of mammography screening have long been debated in the scientific community. According to the National Cancer Institute, while screening may be effective in reducing the number of deaths from breast cancer through early detection of a cancerous tumor, it can, at the same time, cause harm to the woman who is participating.
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Pain Pumps Can Necessitate Further Surgeries

Sometimes a medical device meant to provide relief for patients suffering and expedite healing causes more pain than relief. One of these devices is known as a pain pump, most commonly used in patients recovering from shoulder surgery after a serious shoulder injury.
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New da Vinci Surgical Robot to Hit Market in 2015

Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan.
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Jury Awards $3.27 Million in Transvaginal Mesh Suit

Surgical mesh was developed in the mid-20th century as a way to treat hernias. The implant was originally intended to be placed beneath the skin to patch the hole in the abdomen and block intestines and other tissues from protruding, according to the U.S. Food and Drug Administration. It can be made from either biological or synthetic materials.
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Senators Call for Recall of Power Morcellators

In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).
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Why Report a Defective Medical Device to the FDA

Consumers and patients who have been in injured by defective devices or other unsafe products frequently report these issues to the FDA, as they should. Recent cases relating to defective medical devices as well as products outside the realm of healthcare demonstrate that while it’s the federal government’s job to investigate these claims and promote safe standards across the board, this process is often a lengthy one.
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What Are the Most Common Class I Recalled Devices?

Medical device recalls are on the rise, with patients reporting injuries and problems from defective products more often than ever. The most serious of all FDA recalls is known as a Class I, since that indicates a situation where there is a reasonable chance that exposure to or use of a product could lead to major health consequences or death.
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL
  • Lawyer.com