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Reporting Pediatric Medical Product Issues

Posted on in Defective Medical Devices

In 2012, the FDA received almost 900,000 adverse event and medical error reports from consumers—but only 5 per cent of those reports concerned children less than 18 years of age.

However, reporting adverse effects in pediatrics can help shed important light on these products, especially since most pediatric clinical trials only contain a small number of patients. In addition, a product may be studied in one age group and approved for widespread use but affect another age group in a different way.

Because of this, the FDA has issued steps you can take to report any adverse effects a child has experienced. In 2007, the FDA received reports of serious side effects in children who were exposed to prescription topical testosterone gel products. The contact was accidental, resulting when a child came in contact with the skin of an adult male who was using this product. However, from these complaints the FDA was able to work with testosterone gel manufacturers to create a safer product and identify places on the body where the gel could be safely applied to minimize child contact. They were also able to create stronger warning labels.

Including the correct pertinent information in your report can help speed up the response time. The key facts to include are: product name, type, dose, and how it was administered; how long the product was used; the age of the child; other medications or medical conditions present at time of usage; outcome; child's health care professional; and your contact information.

There are many ways to submit a report. You can use an online form, report it by phone at (800) FDA-1088 or fax at (800) FDA-0178, or by using the FDA postage-paid form 3500 and mailing it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852.

Having an adverse side effect from a medical product can cause serious complications, whether you are a child or adult. If you or a loved one has had complications in response to a defective medical product, speaking with an experienced attorney can help you file a claim. Our attorneys have multiple locations throughout Northern Illinois—so contact us today to set up your initial consultation.

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