Tag Archives | K-Y Jelly

FDA’s Warning Letter to McNEIL-PPC, Inc.

VIA UNITED PARCEL SERVICE Teresa Gorecki Vice President, Quality Assurance McNEIL-PPC, Inc. 199 Grandview Road Skillman, NJ 08558-1311 12-NWJ-17 Dear Ms. Gorecki: During an inspection of your firm located in Skillman, New Jersey, on December 12, 2011, through January 19, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your [...]

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Latest Drug Injury News

Underground Railway Dust May Pose Health Risk

Travelling or working on an underground railway for sustained period of time could have health implications due to concentrations of metal-rich microscopic dust particles.

New Study Helps Understand Why Health Care Costs On The Rise

Although many believe is it medical malpractice suites that are causing the increase in the health care costs, it is actually the fear of them that is partly to blame. Doctors are ordering unnecessary tests and procedures for fear of a patient filing a claim down the road

FDA Issues New Warnings Concerning Tolvaptan

The FDA has issued a drug safety communication concerning Tolvaptan, a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia.

New Antiepileptic Drug Causes Blue Discoloration And Vision Trouble

An antiepileptic drug to hit the market has been known to cause vision troubles and skin discoloration. Almost all patients experienced gray/blue skin discoloration who had been taking the pill for two years. More information is needed to better understand the occurrences.

Medical Mattresses Pose Risk Of Infection And Contamination

The FDA warns that medical mattresses may not be as clean as once perceived. Routine checks on mattresses are advised as any rips, tears, or excessive wear alter the efficacy. The medical mattresses as well as the covers have an expected life depending on the manufacturer, which should not go unnoticed.

Latest Medical Device Injury News

Women 30% More Likely To Need Repeat Hip Implant Surgery

Doctors traditionally believed the larger the size of the implant, the more protective it was against failure, according to Sedrakyan. However, he said his study found regardless of size, women had a higher rate of revision occurrence, so some other factor besides the actual implants may be leading to this effect.

Transvaginal Mesh Lawsuits – Who Is At Fault?

For some women a pelvic transvaginal mesh product has been a god sent.  To be able to resume a full active life, without the worry of a leaky bladder, is a true miracle for some women.  And, this only became possible with the help of pelvic mesh. The mesh is most commonly used after pelvic [...]

Metal-on-Metal Hip Implants Cause Soft Tissue Damage Says FDA

Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip resurfacing. As part of this treatment, they may receive a “metal-on-metal” hip implant in which the “ball and socket” of [...]

Ethicon Recalls Surgical Stapler

The FDA has announced a voluntary global recall of more than 157,000 Ethicon surgical staplers, due to problems with incomplete firing strokes that may cause faulty staple formation, potentially resulting in painful and severe internal complications for the patient. An Ethicon surgical stapler recall was first announced in August, after reports surfaced where surgeons experienced [...]

Another Device Maker Investigated By DOJ

Earlier this month, cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. According to Forbes, the announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had just been [...]