A recall has been issued on oscillating fan heaters under the Kenmore brand due to concerns that they could trigger a fire in the nearby area. 42,500 heaters with a model number of 127.90914310 are affected by the recall, which was announced by the Hoffman Estates, Illinois-based Sears Holdings. The motor mounts can reportedly break, and when that happens, overheating and a subsequent fire are distinct possibilities. Two injuries and five additional smoke or fire reports have already been filed, and so that future damage can be avoided, the company is asking that the items be unplugged at once. Kmart and Sears, the only places where these items were on sale, are accepting returns and will issue refunds as needed. The heaters were available this past September, October, and November.
Click here for more about the recall.
Are you concerned that a cosmetic product you’re using may actually be harmful to your health? If so, then you have some recourse. California officials have just launched a repository of information related to chemicals in cosmetics, and any persons who fear that they might be exposed to dangerous substances would be wise to check it out.
The effort is the result of 2005’s Safe Cosmetics Act, which paved the way for a public database to come online by the end of this past year (although it took a few more days than that to become available). Now, those interested can head to the California State Cosmetics Program Product Database to find out what chemicals are contained in products they have at home right now.
The database provides information on 30,000 products from 475 firms. In terms of disclosure, health officials are pointing out the presence of 900 chemicals that have the potential to inflict harm on a user, as suggested by the National Toxicology Program and other entities. To be subject to the rule, a company peddling its wares in California must accumulate sales of upwards of $1 million on an annual basis.
The one drawback of the database is that it puts safety in the hands of people using the products. A representative of the Breast Cancer Fund points out that the state may be better off with the chemicals not present in the first place.
If an individual suffers adversity related to a medical device or a drug, the Food and Drug Administration hopes that he or she or their doctor files a report on that product through the MedWatch system. This allows the agency to keep track of hazards that could be indicative of serious and widespread problems, and the more people who relate their issues, the safer the country can be.
Now, the FDA has announced a similar system related to any adversity suffered in conjunction with a tobacco product. Previously, persons were able to report tobacco issues, but the platform to do so may have been confusing, as there wasn’t a dedicated portal for tobacco.
That has changed now, and the hope is that this could create uniformity in the way that people report health issues or potential defects related to the products. Tobacco is within the purview of the FDA, and widespread knowledge about how to report danger can help the agency improve safety and crack down on those products that could be harmful (in ways that go beyond how tobacco is already known to be harmful).
The FDA has provided a convenient list of the types of things that should warrant a report through the new system. Labeling issues are grounds for a report, as are issues with product quality and unexpected side effects.
Two years ago, compounding pharmacies were in the spotlight after an outbreak of fungal meningitis claimed the lives of 64 people and sickened hundreds more. Officials were able to trace the contamination back to the Framingham, Massachusetts-based New England Compounding Center.
The issue brought to light a serious problem with compounders, pharmacies that formulate medications in ways that satisfy the unique needs of specific individuals. But as such facilities expanded from their traditional local-centric role to shipping products across the country instead, they entered a regulatory gray area where neither the state or the federal level (as represented by the Food and Drug Administration) was sure that they had authority over the compounders.
This incident has prompted lawmakers to issue sweeping new regulations that would seek to keep dangerous outbreaks related to compounders from happening again. One such rule would see compounders needing to register with the FDA if they want to ship products in bulk. This allows them to be classified as an outsourcing facility, and with that status comes regular inspections, adversity reporting, safety benchmarks, and a fee that must be paid to the FDA.
A new report in Reuters relates this new rule and notes that 11 compounders have already registered in this manner. If a compounder chooses not to take this step, there will be certain limits placed on them and they will exist within the scope of state regulators.
Followers of this blog can see that dietary supplements get recalled on a fairly regular basis. This is despite the fact that supplements aren’t required to go through the same rigorous approval process that medications must be put through before arriving on the market. Typically, a dietary supplement will be privy to a recall alert because it contains a drug substance or makes claims on its labels that have not been proven. These things could bring the product into the realm of an unapproved drug.
Now, the Food and Drug Administration is trying to get the word out about one particular claim that has them deeply concerned. Their targets are any dietary supplements that make the claim they can be used for some type of concussion treatment. This could be an item touting its supposed ability to prevent concussions, to treat them once they occur, or to cure them completely. Some may claim to offer a quicker recovery rate than if they weren’t to be used.
This is problematic for the consumer who buys into the claims, as it could cause them to head back into physical activity before their body is ready. Subsequent injuries can then prove to be far more deleterious than they otherwise would, as there won’t be a medical professional involved in the decision. The other large worry is that an individual will simply rely on the supplement without attaining the actual treatment that could cause them to truly get past the injury.
If more than one concussion occurs, the damage that can accrue in an individual’s brain might be exacerbated dramatically, and if the affected person continues to rely on the claims of an unproven substance, then you could easily picture the type of danger they might find themselves in. Swelling of the brain is a possibility, and they might experience the type of longterm brain damage that stays with them for the rest of their life. A fatality is also a distinct possibility.
The first instance of the inappropriate marketing of dietary supplements for this concussion purpose reportedly involved a company that was specifically targeting military veterans with its supposed ability to aid recovery from traumatic brain injuries. Then, in 2012, the FDA sent warning letters to two companies informing them of a misbranding situation and asking for an immediate correction. Last month, the makers of a product called Anatabloc received a similar letter from the agency.
A consumer health update has been issued by the FDA in a bid to get consumers to understand this threat and how dangerous misunderstandings about such products can be. Please make sure if you or your child suffer a concussion that you seek prompt medical assistance from a reputed doctor so that any potential dangers might be averted.
Card table and chair sets under the Mainstays brand are being recalled by the Bentonville, Arkansas-based Wal-Mart because of a safety issue that has already led to reports of injury. The recall affects 73,400 sets of furniture that were available across the country from Walmart between this past May and November. The chairs are in danger of suddenly collapsing during use, an issue that could cause a person to fall but that could also lead to a finger amputation if their digits are beneath the chair at that time. Ten incidents involving amputations, fractures, sprains, or sore backs have been reported, and the chairs should not be used. A refund can be obtained from Walmart.
Click here for more about the recall.
The da Vinci robotic surgery system from Intuitive Surgical has been in the news in recent months due to reports about patients being injured in conjunction with an operation carried out by one of these machines. The Food and Drug Administration has a database in place where such adversity is supposed to be reported, and the agency itself has pledged to look into the matter.
However, a new report from Bloomberg points out the one crucial flaw of the FDA’s database: not every report gets related to the agency in a timely manner. Although hospitals are supposed to file adversity reports, there isn’t a precise mechanism in place to ensure that occurs, and doctors are not even required to make reports.
This often puts the impetus on patients to bring the matter to the forefront, an issue that can often prove difficult. Bloomberg reportedly conducted an investigation that found there were numerous incidents that took years to be reported appropriately. So while Intuitive may be able to cite a dearth of adversity reports when touting the safety of their product, that dearth of reports isn’t as clear-cut as originally thought.
A spokeswoman for the company pointed out that a report of adversity doesn’t necessarily mean the da Vinci was the cause and that they don’t get made aware of situations that aren’t reported by hospital officials.
Among the issues that have been scrutinized is the training of the very physicians who use the da Vinci.
Users of a dietary supplement known as Mass Destruction are being asked by the Food and Drug Administration to cease usage of that product so that safety can be assured. Recently, the Department of Health and Human Services of North Carolina related to the agency how a user of the supplement had to endure liver failure followed by a subsequent transplant operation. The worry is that the product will contain an anabolic steroid that could prove hazardous to the individuals that come into contact with it. An analysis is currently ongoing in order to determine what ingredients this product could be composed of, and in the meantime, owners are being asked not to use these products and to alert MedWatch of any adversity thought to occur in conjunction with this supplement.
Click here for more information.
If you have trouble getting around your home and have decided to install portable bed rails around your sleeping space, or if you have an elderly loved one who has done the same, then you absolutely must understand the information on hand from the Food and Drug Administration in a new consumer update. The agency has delved into how these items could actually compromise safety in certain situations, and it’s imperative that you do whatever you can to mitigate this danger.
You first must realize that these types of rails are not the same as those that are attached to the bed itself. With portable bed rails, the items are standalone products that have to be properly installed to the unit in question. Some persons may elect to place these in their own homes, while at other times they could be found at various care centers. The hope is that the rails can provide an increase in mobility and act as a type of support for when an individual is having trouble hoisting themselves into or off the bed.
Unfortunately, these items also have a propensity for injury if they haven’t been installed in an optimal manner. Over the course of time, the products could come loose, and then when someone attempts to put their weight on the rail, it could come apart and lead them to sustain a serious injury during the subsequent fall. The other big worry is that they can begin to pull away from the mattress, creating an opening that the person in the bed could fall into. They can then suffer injuries while stuck, especially if they’re unable to seek immediate assistance.
Lest you think this is an exaggeration of the serious damage that a faulty bed rail could do, consider the data that has been compiled by the Consumer Product Safety Commission. Between 2003 and September of last year, 160 incident reports came into the CPSC, and of those, all but five involved the user being fatally injured. These most often affected persons older than 60. A home setting was the site of 90 of the incidents, and around 50% of those persons involved suffered from some type of medical issue. More than nine in ten fatalities were due to entrapment.
Right now, federal agencies are in the midst of compiling safety recommendations related to these products, but until that time, it may be up to you to ensure safety. Make sure that any bed rail installed in your home or that of an elderly loved one is compatible with the bed being used. Follow installation instructions to the tee and check up on the rail often to ensure it hasn’t created too large of an aperture.
Cocktail glasses are being recalled by the Toledo, Ohio-based Libbey Glass because of a possible laceration hazard these items could create. 218,000 glasses under the Bristol Valley brand with a model number of 8555SR are impacted by the recall, which was issued upon the discovery that this glassware could break during usage, a situation that could create jagged edges that cut the user. 16 incidents have come to the fore, and one of those even reportedly contributed to a laceration injury. These items were available for commercial and personal use across the country from the start of 2013 until last month, and owners of said glasses are being asked to cease usage and seek a refund from Libbey Glass.
For more about the recall, click here.