Safe Medical Devices for Children get help with FDA’s MedWatch ‘Adverse Events’ Program
Any parent or caregiver whose child depends on safe medical devices for children has probably wondered about the safety and efficacy of that device, especially with all the press surrounding defective medical devices for adults. The FDA’s MedWatch ‘adverse event’ reporting program makes it easy for adults to report concerns regarding medical devices for children.
While most children do not question if the medical device they are using is a safe medical device for children, their parents and caregivers may, and need a direct link to the agencies that ensure consumer safety. For this reason, the FDA created the MedWatch program. As with their adult device counterparts, all safe medical devices for children on the consumer market have undergone clinical trials and garnered approval by the U.S. Food and Drug Administration.
However, according to Dr. Dianne Murphy of the FDA’s Office of Pediatric Therapeutics (OPT), “Most pediatric clinical trials involve a relatively small number of patients,” which means that problems with the safe medical devices for children or drugs might not be indentified until they are in widespread use. These problems often remain unknown to the FDA until parents and caregivers inform the agency about them. Still, only about 5 percent of the 900,000 adverse event and medication error reports filed with the FDA’s MedWatch system last year were for children.
In light of this fact, The Cochran Firm – Ohio is working to make more parents and caregivers aware of the MedWatch ‘adverse event’ reporting program in an effort to increase the safety of medical devices and drugs for all children.
Reporting Issues with Safe Medical Devices for Children
By filing accurate and detailed reports concerning safe medical devices to the FDA, parents and caregivers play an important role in not only the safety of their own children, but all children who rely on medicines and medical devices for therapies and treatments.
Parents and caregivers can report ‘adverse events’ through the FDA’s MedWatch reporting database if any of the following are experienced:
- Unexpected side effects
- Serious side effects
- Serious injuries
- Accidental exposures
- Product quality issues including malfunctions
- Therapeutic failures
We encourage parents and caregivers to contact the FDA when something goes wrong or parents have a concern about a medicine or safe medical device for children.
Reporting Adverse Events
There are three ways parents and caregivers can report adverse events to the FDA:
- Through the Online Reporting Form
- Call the FDA at 1-800-FDA-1088
- Download a copy of the form, fill it out, and either fax it to the FDA at 1-800-FDA-0178, or mail it in using the address on the form.
About the Cochran Firm – Ohio
The Cochran Firm – Ohio, is an experienced full service, personal injury law firm with offices in Cinncinati and Dayton and handles personal injury cases throughout all of Ohio. Founded over 40 years ago by famed attorney, Johnnie L. Cochran, Jr., The Cochran Firm – Ohio, has established itself as one of the premier personal injury law firms in the United States and has been recognized for delivering successful results to their clients across a broad range of claims stemming from car / auto accidents, personal injury, wrongful death, medical malpractice, nursing home abuse, premises liability, and product liability lawsuits. For over 40 years, The Cochran Firm – Ohio’s team of experienced lawyers continually fight for justice for all it’s clients. If you’ve been injured call Ohio’s experienced full service law firm “The Cochran Firm – Ohio” today at 513-381-HURT.