Group Action Lawyers
Latest News & Updates

alert
May 08, 2017
Lithium-ion batteries in a medical device can cause smoke and sparks if dropped

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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exploding airbags
May 04, 2017
Over 48,000 Mercedes-Benz SUVs recalled to fix dangerous airbag defect.

Several Mercedes-Benz models have been recalled due to a defect in their airbags. A failure in calibration has reportedly led to a software flaw that doesn’t always deploy airbags when needed.

Regulators investigating the matter noted:

“The front passenger seat Occupant Classification System (OCS) calibration may be incorrect, and as a result, the system can incorrectly classify the occupant as a child seat, deactivating the front passenger air bag.”

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recall
May 02, 2017
The Government has issued a medical drug alert alongside a voluntary recall of Viridal Duo Powder amidst concerns over defective cap seals compromising the sterility of the contents.

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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breast implant concerns
April 28, 2017
A woman fighting a rare but deadly cancer linked to breast implants speaks out to warn others

Ms Stacey Boone had gone to the doctors multiple times and was turned away, dismissing her concerns as having just contracted the flu. It took an egg-sized lump on her collarbone and a 42 pound weight loss before the doctors finally gave her the correct diagnosis.

Ms Boone had stage 4 cancer.

The type of cancer she was diagnosed with is extremely rare. The breast implant is associated with anaplastic large cell lymphoma (ALCL), which is a type of non-Hodgkin’s lymphoma. It is a cancer in the lymphatic system which is essentially the immune system.
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April 27, 2017
CareFusion syringe pumps are incompatible with any syringe type

Following on from medical device alerts from the Medicines and Healthcare products Regulatory Agency (MHRA), CareFusion has made updates and replacements to the MDA/2016/023 Alaris syringe pumps that were at risk of having uncontrolled bolus i.e. chewed up amounts of substances from the medicine.
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April 25, 2017
Mylan EpiPen recall information

Anaphylaxis is a life-threatening reaction to certain allergens which can be found in foods, drugs, and even venom like in a wasp sting. Depending on the sufferer’s sensitivity to the allergens, anaphylactic shock can be caused by ingestion or even mere contact on skin.

Otherwise more commonly known as an allergic reaction, without the simple treatment, the consequences can be serious and even fatal. Anaphylactic shock can come on immediately, and in severe cases, symptoms can develop just as quickly. Some symptoms include swelling of the throat and face; wheezing; dizziness and fainting spells. If left untreated, individuals may have difficulty breathing to a point where they may stop doing so.

For these reasons, any life saving EpiPen recall is always a major concern.
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drugs
April 19, 2017
Class 3 recall: does the small crack in the blistering of tablet packaging impact their effectiveness?

The Medicines and Healthcare products Regulatory Agency (MHRA) has recommended recalling instant pain relief tablets due to an issue with some batches.

Bayer plc is a pharmaceutical company who manufactured the pain relief tablets in question; Alka-Seltzer Original & Alka-Seltzer XS. Bayer noticed an issue with the blister foil and as a result, are voluntarily recalling them as a precautionary measure.
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April 17, 2017
All batches of Reflection’s dead blow mallets are to be quarantined and returned to the manufacturer due to lead beads escaping into surgical wounds.

All of the dead blow mallet hammers manufactured by Smith and Nephew have been recalled after reports of broken mallet heads were made.

The dead blow mallets are different to conventional hammers as they are made to apply more precise pressure and less damage to the surface struck. The minimal elastic rebound is usually created by leaving the hammer head hollow or filled with loose sand, steel beads, or lead beads. However, this means that, if they break or crack, the filling could spill out, and this has resulted in the recall.
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medical device alert
April 11, 2017
Manufacturers of vital ventilation machines issued a Medical Device Alert after reports that the emergency devices stop working due to oxide build up.

Drager has issued a ‘risk of failure’ alert to all users after multiple reports were made complaining that ventilation devices had stopped working.

This is reportedly not the first time the company has received these complaints. Dräger has now issued a second Field Safety Notice for the Oxylog 3000 and Oxylog 3000 plus ventilators.
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April 07, 2017
Vaginal meshes used to treat bladder problems still causing catastrophic problems

Thousands of women worldwide have experienced catastrophic injuries as a result of having a synthetic transvaginal mesh, transvaginal tape, or a bladder sling implanted.

The net-like implant is commonly used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Common side effects reported from the use of the vaginal mesh implants include continuing urinary incontinence; recurrent bladder infections; erosion; haematomas; nerve damage; inability to have sexual intercourse; pain during sexual intercourse; auto immune reactions; and life-long disabilities and even death.
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drugs
April 06, 2017
MS Tecfidera medication caused liver injury to 14 people

Pharmaceutical company Biogen Inc has recently received a scare from its big-selling oral multiple sclerosis drug, Tecfidera.

Tecfidera has been well-known to treat relapsing multiple sclerosis, and although, Tecfidera’s historic side effects have been linked with serious viral infections to the brain, which could lead to disability or death, more recently, the medicine has been linked to liver injuries.

Of the 230,000 patients treated with Biogen’s Tecfidera, there have been 14 reported cases of liver injury, according to a Biogen spokeswoman.
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alert
April 04, 2017
Heart pump device production has been halted due to patient death

A medical device manufacturer has stopped the production and use of a heart pump device following the death of a patient.

Abbott Laboratories, an American-based worldwide healthcare company, has halted the use of the HeartMate PHP catheter following a patient death and several malfunctions in the U.S. and in Europe.

The device was initially thought to be commercially promising, but the problems identified are serious.
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