Notify FDA of Adverse Events with Medications and Medical Devices

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Ennis & Ennis, P.A. Recommends Patients Complete MedWatch Form to Notify FDA of Any Adverse Events Caused by Medications or Medical Devices

Patients must be proactive in protecting themselves and others from bad drugs and defective medical devices.

In a world of endless technology, there are so many unused informational resources for patients. According to Ennis & Ennis, P.A. one of the single most helpful resources for patients is the U.S. Food and Drug Administration (FDA) website. In addition to having the ability to research data on drugs and medical devices, the FDA website also allows a consumer to easily report adverse events experienced with FDA-regulated drugs, medical devices, nutritional products and cosmetics.

“It is critical that the FDA be notified of an adverse event,” commented Attorney David Ennis. For example, just last week, an FDA advisory panel met to discuss the risks posed by transvaginal mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). At this meeting, the manufacturers of the mesh devices reported that the overall Medical Device Reporting rate for the mesh devices indicated that the adverse events rate was low, with an average rate of 0.13% for the 2008 to 2010 period. “That rate fails to take into account all of the women who did not report their adverse event,” responds Ennis. “Of my hundreds of clients with potential transvaginal mesh claims, only approximately 3% have reported it to the FDA,” reports Ennis. “Patients must be proactive in protecting themselves and others from bad drugs and defective medical devices.”

One reason for the low report rate is the lack of knowledge. Another factor is the required information to submit a claim. For drugs, the FDA form requires a product name, label strength, Lot #, NDC # and manufacturer. For medical devices, the form requires a brand name, common device name, Lot # and manufacturer name, city and state, which can only be obtained from the patient’s medical records.

While it may be inconvenient for a patient to obtain medical records, the filing of an adverse event report is the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.

Ennis & Ennis, P.A. advises that there are four methods in which to report an adverse event:
Online – Visit https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm and complete an on-line form.
Mail - Download the form at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm and mail it in.
Fax – Download the form from the website and fax to 1-800-FDA-0178.
Phone - Call 1-800-FDA-1088 Mon–Fri between 8:00 a.m. and 4:30 p.m. EST.

Ennis & Ennis offers free nationwide, confidential, consultations to individuals who have suffered injuries caused by medication side effects, defective products and defective medical devices by calling toll free 1-800-856-6405 or by visiting http://www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies as well as medical device makers. Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Transvaginal Mesh Implants, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Yaz, Yasmin and Ocella Birth Control Pills.

Remember the law limits the time you can file a claim, so don't wait to explore your legal rights. Call toll free 1-800-856-6405 or visit http://www.ennislaw.com.

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Attorney David Ennis
Ennis & Ennis, P.A.
1(800) 856-6405
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