The FDA Needs Your Help in Reporting Bad Drugs or Medical Devices

Over the years there have been many tremendous advances in drugs and product technology that help people live longer and healthier lives and kudos to the companies that pioneer this research. Recently however, there seems to be more and more recalls as companies rush products to market without enough research and are “fast-tracked” by the FDA to get drugs and medical devices to consumers more quickly. That being said, we want our clients, friends and families to know there is a system in place for voluntary consumer reporting to the FDA if you have a bad reaction to a particular drug, or been injured as a result of a faulty medical device.

The FDA relies on consumers to play an active role in the health care system. MedWatch is a safety information and voluntary adverse effect reporting system created by the FDA so consumers can quickly and easily report adverse events online.

Consumers who were injured or suffered a bad reaction or side effect to a drug or medical device should use the MedWatch Consumer Voluntary Reporting form (Form FDA 3500B) found at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery. This includes:

  • Prescription and over-the-counter drugs
  • Medical devices such as pacemakers, diabetes drug testing or breast implants, to name a few
  • Biologics used for transplant like tendons or bone
  • Nutrition products including vitamins and minerals, infant formulas and specialized nutrition products to treat a specific disease or condition
  • Make-up and cosmetics products
  • Foods and beverages

If you or a loved one have been injured or suffered any ill effects from drugs or a medical device, the first step to reporting is to fill out the MedWatch form. The FDA will not share your personal information with the public but will use the information you provide to determine if the product needs to be recalled to protect the public.

Next, call an experienced personal injury attorney. You may be entitled to compensation for any ill effects or lasting problems caused by a drug, or bad medical device. The law firm of Bubalo Law PLC is experienced in such cases and is available to answer any questions.