Automaker Fiat Chrysler under-reported a “significant” number of deaths, injuries and legal claims that it was obliged to reveal to regulators, according to the National Highway Traffic Safety Administration (NHTSA).
The federal regulator announced the under-reporting after Fiat Chrysler said it had discovered “deficiencies” in its system for reporting defects under the Tread Act, a law that specifies the information car makers must submit to regulators, CNBC reports. Continue reading
Health Canada, Canada’s health regulatory agency, has updated the label information for the multiple sclerosis drug Gilenya (fingolimod) to include stronger safety warnings on the risk of skin cancer and the rare brain infection progressive multifocal leukoencephalopathy (PML), which can be fatal.
Gilenya, a prescription drug, is used in the treatment of relapsing-remitting multiple sclerosis (MS) to reduce the frequency of attacks (relapses) and delay the progression of physical disability. Gilenya is used specifically when other MS treatments have not been effective or cannot be tolerated, Health Canada explains. Continue reading
Chewbeads Inc. has recalled more than 45,000 pacifier clips in the United States and Canada because they may pose a risk of choking for babies. According to the Consumer Product Safety Commission, the New York-based company had received seven reports of beads detaching from the pacifier clips, but no injuries can been reported thus far.
Fox News reports that five styles of Chewbeads Bay pacifier clip holders are affected by the recall, including those with shapes of a butterfly, a dinosaur, a heart, a sheriff’s badge, a white baseball with red stitching and a major league baseball team logo. The pacifier clip holders are called “Where’s the Pacifier?” and contain eight multi-colored beads threaded on a satin ribbon. The beaded ribbon is attached to a pacifier on one end and a plastic D-ring on the other; the product is about 6 inches long in total. Recalled clips have one of the following codes on the back: 3/31/14, 08/08/14, 12/01/14, 14/30/09, 15/02/09, 25/04/14. Continue reading
As part of an internal restructuring related to its $49.9 billion merger with Covidien, Medtronic will pay a one-time tax charge of $500 million so that it can bring $9.8 billion in overseas cash to the United States.
This move is the result of the tax inversion deal that relocated Medtronic from Minnesota to Ireland, where corporate taxes are much lower. Medtronic could use the extra cash to fund more acquisitions, Med Device Online reports. Continue reading
Three people have died and hundreds have become ill after they ate tainted cucumbers imported from Mexico.
The Centers for Disease Control and Prevention (CDC) says there have been 558 cases of salmonella poona infections linked to the cucumbers in 33 states, with 140 new cases reported to the CDC between September 15 and September 22, Vice News (vice.com) reports. Continue reading
For some, the deadline to register for the September 11th Victim Compensation Fund (VCF) is quickly approaching. According to The PBA Beat, members who were diagnosed with prostate cancer on or before October 21, 2013 must register with the Fund by October 21, 2015 to protect their eligibility to file a claim. The VCF provides compensation to responders and survivors who suffered injuries and economic losses due to 9/11. For more information, claimants may view www.vcf.gov or call (855)885-1555.
The Zadroga Act, signed into law in early 2011, reopened the VCF and created the World Trade Center (WTC) Health Program. These programs provide aid to 9/11 responders and survivors who developed health problems after being exposed to hazardous substances during and in the aftermath of the attacks. The WTC Health Program is monitoring over 70,000 people and providing medical treatment to 33,000. These programs are due to expire unless Congress chooses to renew the Act. The WTC Health Program will lose funding in October, and rely on cash reserves into next year before it ends entirely. The VCF is slated to expire next October. Continue reading
The Food and Drug Administration (FDA) has issued a safety communication, warning that the automatic clutch mechanism in some cranial perforators—devices to drill into the skull—may fail to disengage and automatically stop drilling after the skull is penetrated, injuring the patient.
Most cranial perforators are designed to automatically stop drilling in order to prevent the tip from unintentionally drilling or “plunging” into the brain. But the clutch mechanism may fail to disengage if the device selection and proper use are not in accordance with the manufacturer’s instructions and the patient can be injured, the FDA warns. Continue reading
A Food and Drug Administration (FDA) advisory panel has recommended that the label for the Essure birth control device clearly state that Essure is a surgical device and the implant should come with more comprehensive instructions for insertion and follow-up monitoring.
After extensive discussion of post-marketing data, peer-reviewed studies, and hours of patient comments about the Essure device, the agency’s Obstetrics and Gynecology Devices panel offered suggestions for best practices, stronger patient education, and increased collection of data, Medpage Today reports. Continue reading
The Consumer Product Safety Commission (CPSC) has announced the recall of Zak Designs 26-ounce plastic water bottles that could present a choking hazard.
The 10-inch tall water bottles have a flip-top spout on a twist-off cap with colored inner plastic straws in clear, blue, gray, green, light purple or red. In the recalled bottles, the inner plastic straw in the flip-top portion of the twist-off cap can break, posing a choking hazard. Continue reading
Supermarket chain Giant Food of Maryland issued a recall of Koch Oven Cravers frozen, raw, stuffed, and breaded chicken products manufactured by Chicago-based Aspen Foods.
Consumers are being informed that Giant is pulling these products off store shelves because the chicken products may be contaminated with salmonella, Meat & Poultry (meatpoultry.com) reports. Continue reading