Tag Archives: Medical device

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Do Vitamin Drinks Pose Health Risks?Do Vitamin Drinks Pose Health Risks?

Do Vitamin Drinks Pose Health Risks?

Scientists are concerned vitamin drinks are contributing to levels of vitamins and other nutrients that are not only unnecessary, but potentially harmful.

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Fracking Releasing Hazardous Chemicals into Local Waterways

Fracking Releasing Hazardous Chemicals into Local Waterways

Study shows two hazardous chemicals—ammonium & iodide—are being released & spilled into Pennsylvania and W.Virginia waterways from fracking operations in Marcellus shale.

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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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MTA Bus Crash and Two Cars Injures 23 at Utica Ave. & Clarendon Rd

Crash Involving MTA Bus and Two Cars Injures 23

Police are investigating an accident in Brooklyn on Wednesday afternoon that injured 23 people, 3 of them critically, when a car was knocked into the path of an MTA bus.

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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

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Federal DePuy ASR Hip Implant Trials Likely to Start This Year

It looks as though the first trials in the DePuy ASR hip implant multidistrict litigation could begin sometime later this year. According to a report from Bloomberg News, during a status conference held yesterday in Florida, attorneys for both plaintiffs and the defense told U.S. District Judge David Katz that ...

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Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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Medtronic Uses Preemption in Medtronic Infuse Case, Again

Medtronic Uses Preemption in Medtronic Infuse Case, Again

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse | Tagged , , , , |

New Legislation Outsources Medical Device Safety Reviews

Medical-Device-Safety-Reviews

Consumer groups and health advocates are concerned about legislation just passed by the House of Representatives that would make it easier for medical devices to reach the market and would put safety determinations in the hands of subcontractors paid by … Continue reading

Posted in Defective Medical Devices, Defective Products, Health Concerns | Tagged , , , , |

FDA Warns of Possible Patient Injury if Coating Separates from Intravascular Medical Device

Coating on Medical Devices Can Cause Patient Injuries

The Food and Drug Administration (FDA) has issued a safety communication warning of the possibility of patient injury if the hydrophilic and/or hydrophobic coatings on medical devices separate—peel, flake, shed, delaminate, slough off—during use. A number of factors can cause … Continue reading

Posted in Defective Medical Devices, Health Concerns, Product Recalls | Tagged , , , , |

European Medicines Agency Seeks Market Suspension of Medtronic InductOs

Euro Medicines Agency Seeks Suspension of Medtronic InductOs

The European Union’s medical device regulator has recommended suspension of the marketing authorization for Medtronic’s InductOs bone growth device until issues at a U.S. plant that makes a component of the device are resolved. The European Medicines Agency (EMA) launched … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse | Tagged , , , |

Device Used During Surgery Linked to 8 Infections, 4 Deaths at PA Hospital

Device Used During Surgery Linked to 8 Infections, 4 Deaths

A device used to heat and cool a patient’s blood during heart surgery has been linked to infections in 8 patients at a Pennsylvania hospital. The New York Times reports that four of those patients have died, but it is … Continue reading

Posted in Defective Medical Devices, Legal News | Tagged , , , , |

Newly Launched FDA Website Tracks Medical Devices

Newly Launched FDA Website Tracks Medical Devices

The U.S. Food and Drug Administration (FDA) has announced the launch of its online Global Unique Device Identification Database, AccessGUDID, which allows the public to track medical devices through unique identifiers. Through this site, company-submitted information can now be looked … Continue reading

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Justice Department Fines Medical Device Makers over $110 Million

Justice Department Fines Medical Device Makers

The U.S. Department of Justice and U.S. Department of Health and Human Services released their joint annual report on health care fraud and abuse control on March 19th. According to the report, the federal government won or negotiated roughly $3.3 … Continue reading

Posted in Defective Medical Devices, Legal News | Tagged , , , , |

Justice Department Settles False Claims Case with Medtronic for $4.4 Million

Justice Department Settles False Claims w/Medtronic

In an announcement last week, the U.S. Department of Justice said it had reached an agreement with medical device maker Medtronic for violations of the False Claims Act. The announced settlement is $4.4 million. The Justice Department brought action against … Continue reading

Posted in Defective Medical Devices, Defective Products, Legal News, Whistleblower | Tagged , , , , |

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