Tobacco Case Study

A parent of a healthy 16-year-old student received a call from the school nurse that her teen was found in the school bathroom having a seizure. An ambulance transported the teen to the local emergency room. An e-cigarette was found on the floor next to him. The emergency room tested for nicotine levels in his system, with results pending. Other testing and follow-up visits to date with his pediatrician and neurologist have not identified any underlying disorder or other cause for a seizure. The teen admitted to using the e-cigarette which he had purchased from a gas station near the school.

Where is the best place for the parent to report the health problem?

Where is the best place for the school nurse, ambulance crew, emergency room staff, pediatrician, and/or neurologist to report the health problem?

How do I report a problem with a Tobacco Product?

What Information should I put in a Tobacco Product Problem Report?

Details about adverse experiences are important in helping FDA to identify concerning trends and clear patterns or causes for particular incidents.

When reporting an adverse experience, please be sure to include information about:

• The affected person (whether a user or nonuser)
• Manufacturer name
• Brand name, model, and serial number of the product, device, or e-liquid, as applicable
• Where the tobacco product(s) were purchased
• Whether the tobacco product(s) were modified in any way or whether there was a device malfunction
• Use of or exposure to other tobacco products, medications, supplements, substances of abuse or toxins around the same time
• Any other symptoms or warnings before the adverse experience, such as nausea, vomiting, change in the user’s behavior, alertness, vision or hearing
• Details about the pattern of product use or exposure before the event (duration, amount and intensity of product use) as well as the time between the latest use and the adverse experience
• Health effects details: Specific areas of the body affected, symptom progression, how long symptoms lasted, course of recovery, and any medical testing, care and treatment decisions rendered
• Underlying health conditions, health history and family history
• Whether product use continued or not after the event and whether additional events occurred
• Whether you reported the event elsewhere, such as to a poison control center, the retailer, or the manufacturer

You can also upload relevant medical records, photos, or other files that include or supplement this information. Follow-up reports to the SRP weeks, months, or years later that are linked to the initial report and give final outcomes can also be useful.

• Problems with Tobacco Products: Consumer Update
• FDA Information on Tobacco Products

Biologics Case Study

A 76-year-old male with type 2 diabetes mellitus recently had his second dose of a vaccine to prevent a virus. He experienced a sore arm and almost exactly at 48 hours post immunization, a large rash appeared around his neck and upper torso. The rash was warm to touch, very patchy, and itchy. The next day the rash had spread to the entire torso.

Select the appropriate reporting method for the case.

Limited English Proficiency Case Study

My 83-year-old mother lives in Puerto Rico. A severe hurricane recently impacted her access to electricity. She wants to report a problem that she is having with a new diabetes medication but is not sure how to do so. Although she is bilingual, she is more comfortable communicating in Spanish. She has a local library within walking distance of her home. The library has electricity and provides residents access to computers.

Select the appropriate reporting method for the case.