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What Makes a Medical Device Defective?

Posted on in Defective Medical Devices

Though medical devices are meant to help those who need them to live healthy and productive lives, there are risks involved in the use of a medical device. If the device does not work properly, is not used properly, or begins to break down, it can cause more problems for the person using it. The following will help you understand what makes a medical product defective, and what to do if you encounter a defective device.

In order to bring up the issue of a defective medical device in a court of law, it must be defective in one of the two following ways:

  1. The design is defective. This means that if the device is in proper condition and is used according to the directions, it will be harmful to the user.
  2. The product is defective. This means that the device was designed in a way that would help the user, however it was poorly constructed, and does not work properly.

Understanding these two definitions of a defective device can help you determine whether or not you have a case. Contact an Illinois defective medical devices lawyer today with questions.

The FDA will often post recalls of devices that it knows are defective. Check with Federal Drug Administration (FDA) and see if there are any recalls posted on their website. The FDA reports all problems and issues for the public as well may make the manufacturer use warning statements. There are three types of recalls that you can look for.

  1. Class I recall is the highest risk and given when death or serious injury. Usually a press release from the FDA is released and they force the company to contact the users of the product of the recall.
  2. Class II recall is lesser however it can still cause serious injury or create health complications that cannot be reversed. No press release is done by the FDA.
  3. Finally, a Class III recall is the less serious of the three because it will not cause serious injury and does not go against the FDA law in any way. No press release or contact is required.

Regardless of the recall class, if you have been affected by a medical device being defective you should contact a defective medical device attorney in Illinois who has the experience to win cases against recalls.

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