Following a medical device alert back on the 21st April this year, LMA MAD Nasal has recalled their intranasal mucosal atomisation devices after complaints that the device failed to deliver medication properly.
The device provides an alternative administration of medication that otherwise may require a needle. Marketed as “safe, painless and rapidly effective treatment”, many may prefer the nasal atomiser over a sharp needle in the arm.
However, problems have arisen where the medication may not actually be delivered properly or at all, which can of course be incredibly dangerous for users relying on vital medication for their health.
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British soldiers deployed abroad in certain tropical countries may be prescribed drugs to prevent contracting malaria. For many years, troops were prescribed Lariam, but for over a decade there have been a whole string of complaints that it causes significant psychological problems.
Various countries all over the world stopped prescribing or selling the drug amidst fears that Lariam causes depression and violent behavioural changes, and our lawyers are investigating the issues surrounding use of the drug.
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Pharmaceutical company GlaxoSmithKline (GSK) are recalling hundreds of thousands of reportedly defective asthma inhalers.
The life-saving medical devices help asthma sufferers breathe, especially when suffering from asthma attacks, but a reported defect in the Ventolin inhalers has been found to provide insufficient doses.
The drug company, based in the U.K., supplies asthma inhalers to hospitals, pharmacies, retailers and wholesalers around the world, with defective units being found in the U.S.
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Over the past few years, we have seen the digital world explode and incorporate in to everything we do. We have apps and gadgets for all sorts of things!
The medical industry has grasped this fairly new development to improve medical equipment and devices too. With ever advancing technology in treating patients, different medical companies are joining forces to introduce upgraded robotics, better visualisation, and improved bioelectronics.
However, the advancement of creations and collaborations have also seen a similar rise in medical device failures and the ever-present risk of hacking…
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The Washington Supreme Court in the U.S recently gave a 6 – 1 judgement on whether or not medical device manufacturers have a responsibility to warn hospitals as well as doctors and operators of the risks their products come with.
In this recent Supreme Court decision, it was held that manufacturers must also warn hospitals as the purchaser of the medical devices (and thus the consumer), as well as doctors. The lawsuit was made against Intuitive Surgical Inc. after a man died from a fatal operation involving the manufacturer’s robotic medical device. The Da Vinci system is used for minimally invasive operations whereby a doctor operates on the patient through a robotic arm controlled by an electric remote.
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Following on from the recall issued by De Puy Orthapaedics on their hip implants in 2012, a recent decision has been made at the Court of Appeal over the defective hip replacement devices, where the Court has decided that a safety expectation test must be passed too.
Whilst the claimant Wilkes had suffered from an implant fracture 3-years after the hip replacement implant, the Court looked towards surrounding circumstances like ‘risk benefits’ and how it could have been avoided.
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Medtronic has issued a worldwide recall over their unused StrataMR valve devices after numerous complaints have been raised.
In one of the complaints, one patient death is suspected to be related to the device. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent Field Safety Notice to distribute news of the recall in the U.K.
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Zimmer NexGen knee implants are supposed to provide patients with new artificial knees to last at least 15-20 years. However, there have been numerous reports that the implants have been loosening; causing pain, discomfort and other complications.
With the level of complaints, the implants are believed to be defective and a recall has been issued by the U.S. regulators. However, this isn’t a broken toy that you can just bring to a supermarket for a refund; individuals who have had the knee replacement surgery may be at risk of the implant moving or loosening, and if this occurs, the individual may need knee revision surgery.
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Regulators have found 65 fake health products circulating the web that are falsely advertised as cancer treatments.
“Miraculously kills cancer cell in tumours,” “more effective than chemotherapy” – These kinds of potentially fraudulent and unsubstantiated claims are being used to advertise alternative cancer remedies, and the concern is that the vulnerable are being preyed upon.
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How long is too long?
It seems that medical device companies do not prioritise the safety of their products above profits and reputation, as a study conducted by the University of Minnesota revealed that these companies tend to delay in recalling defective products.
When problems are not reported to relevant authorities – like the MHRA here in the UK – healthcare professionals and the public may be unaware of the complaints, and thus may continue to use defective products that may carry a significant risk of harm.
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Damaged lithium-ion batteries in a medical device have been a cause for concern for the Medicines and Healthcare products Regulatory Agency (MHRA).
The CARDIOSAVE hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE rescue IABP have been reported to have damaged lithium-ion batteries that may give off smoke, a bad smell, or produce sparks.
Macquet, the manufacturer of the medical device, has warned users to avoid carrying spare batteries when transporting the IABP to reduce the risk of dropping and damaging them.
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UCB Pharma Limited is voluntarily recalling their Viridial Duo Powder and Solvent for Injections after concerns that the cap seals are not strong enough. The cap seals are vulnerable to breaking and thus compromising the sterility of the contents.
Viridal Duo Powder and Solvents contain the active ingredient ‘Alprostadil’ and is used for adult males for diagnostic evaluation and treatment of erectile dysfunction. The prescription only injections for diagnostic evaluation purposes are carried out by a trained physician, who will monitor the dose need to produce an erectile response.
For the treatment of erectile dysfunction, this can be administered by a physician or by self-injection.
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