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September 2014 Archives

FDA Announces Largest Ever Medical Device Recall

6310985_s-300x200 (1).jpgLast month, the U.S. Food and Drug Administration (FDA) issued a massive medical device recall that is the largest single-day recall ever. The recall involved devices made by Puerto Rico-based manufacturer Customed, Inc. and was given a Class I recall classification - the FDA's most serious recall classification , which is used in those cases where "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." According to an article by the Regulatory Affairs Professional Society (RAPS), the FDA typically recalls between 3 and 75 devices each day, with the overwhelming majority of those recalls either Class II or Class III recalls which reflect lesser (and non-deadly) safety risks than Class I. But on August 29, 2014, the FDA posted 233 Class I recalls, all of which were for devices manufactured by Customed due to packaging flaws. In a warning letter issued on August 26, 2014, the FDA recommended that customers who have products stop using the product lots included in the recall. Customed, Inc. has notified its distributors by mail and arranged for the products return. Customers with questions about this recall may contact Ms. Wanda Cotto, Recall Coordinator, at (787) 801-0100 Ext. 7540, Monday through Friday, 8:00 a.m. - 5:00 p.m., Eastern Time. The FDA also advises healthcare professionals and patients to report adverse events or side effects related to these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by:

Slip and Falls and Other Common Premises Liability Claims

 aSlipFallIcon_vectorstock_1841583-300x300 (1).jpg Slip and falls are a common personal injury accident. If a slip and fall accident happens on the property of another, the property owner could be liable for the resulting injuries. Under the premises liability laws, property owners and managers have an obligation to safely maintain the property and they can be held liable for any accidents, injuries, or deaths which occur on their property due to their negligence in the design or maintenance of the property or their failure to warn of the danger. Slip and fall accidents are one of the most common types of premises liability lawsuits, but they can also involve other accidents and injuries. Common types of premises liability accidents include:

What Is Nursing Home Abuse and Neglect?

9841759_s-300x200 (1).jpg Nursing home abuse is elder abuse within an institutional setting. Nursing home abuse can include inadequate medical treatment, physical abuse, emotional abuse, financial abuse, and neglect. In fact, neglect is one of the most common types of nursing home abuse. Elder abuse can also happen outside of nursing home facilities, such as home health care.  

Surgical Malpractice Risks

  8943758_s-200x300.jpg Surgery - even relatively minor surgeries - can present a number of risks. Learn more about how to protect yourself from some of the more common surgical malpractice risks:

Back-to-School Safety Tips for Parents and Caregivers

 pKidsGetOnBus_6215772_s-300x197.jpg September means heading back to school for many families. While a new school year is an exciting time for children and parents, it can also be a stressful time for many families. The following are some back-to-school safety tips for parents and caregivers to keep in mind as they send their children off to school:

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