Tag Archives: superbug

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Exploding Tanks Kill Jeep Drivers 18 months after Recall

Exploding Gas Tanks Continue to Kill Jeep Drivers 18 months after Recall

Chrysler recalled Jeeps with exploding gas tanks more than 18 months ago, but 1 million+ of these vehicles have not been fixed as the death toll continues to rise.

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Transvaginal Mesh Lawsuit Trial

$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial

An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation Lawsuit

A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports.

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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Senate Report Critical of Medical Device Makers’ Failure to Report Infections

duodenoscopes

A Senate report released on January 13, 2016 finds that superbug infections linked to poorly cleaned medical devices have been more widespread than previously known. The reports places blame on hospitals, device makers, and the Food and Drug Administration (FDA). … Continue reading

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

Olympus Faces Wrongful Death Lawsuit over Contaminated Duodenoscope

Olympus Faces Wrongful Death Lawsuit over Duodenoscope

A wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp. and Custom Ultrasonics has been filed over the use of an allegedly contaminated medical scope. The suit was filed on behalf of a woman whose husband died of an … Continue reading

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

Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers

FDA Mandates Safety Studies from Scope Manufacturers

The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The … Continue reading

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Medical Scope Makers Warned in the Wake of Superbug Outbreaks

Three manufacturers of duodenoscopes—specialized medical scopes—have received Food and Drug Administration (FDA) warning letters because the scopes have been linked to outbreaks of a deadly “superbug.” The FDA says the companies failed to adequately report problems with the devices and, in … Continue reading

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

Gastrointestinal Scope Makers Receive FDA Warning Letters

Gastrointestinal Scope Makers Receive FDA Warning Letters

The Food and Drug Administration (FDA) sent warning letters to the three makers of a specialized gastrointestinal scope that has been linked to outbreaks of superbug infections at U.S. hospitals. In the spring, the FDA conducted inspections of the manufacturing … Continue reading

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

Olympus Receives FDA Warning Letter for Failing to Notify Agency about Superbug Infections in Required Time

Olympus Receives FDA Warning to Notify about Superbug

Gastrointestinal scope maker Olympus Corp. waited three years to alert federal regulators about 16 patient superbug infections the company learned about in 2012. The Food and Drug Administration (FDA) cited that lapse in reporting and other safety-related violations in warning … Continue reading

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

Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago

Emails Show FDA Was Warned of Duodenoscope Infection

The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks. In 2009, after duodenoscopes were linked … Continue reading

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

FDA Knew Medical Devices Can Transmit Superbugs but Did Not Act

FDA Knew Medical Devices Transmit Superbugs but Did Not Act

Experts in hospital-acquired infections say that health regulators have known since at least 2009 that certain reusable medical devices can transmit lethal infections but have not recommended any new safety requirements. The latest outbreak involving duodenoscopes may have exposed 179 … Continue reading

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Warning to UCLA Hospital Patients Exposed to Drug-Resistant Superbug

Warning to UCLA Hospital Patients Exposed to Superbug

One hundred seventy-nine patients at UCLA Ronald Reagan Medical Center have been told they may have been exposed to a drug-resistant “superbug” during endoscopy procedures that infected seven patients and may have contributed to two deaths. Patients who may have … Continue reading

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

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