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U.S. Department of Health and Human Services

Consumers: Case Study 1 – Cosmetic

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Jane B. is a 32-year-old female who visited her usual hair salon on August 18 for a hair treatment to relax, smooth, and straighten her hair. The stylist began by washing and towel-drying Jane’s hair, and then applied the straightener. During the blow drying process Jane noticed fumes and vapors. She found breathing difficult and had chest pain and itchy, watery eyes. As her hair was being ironed, Jane developed a strong cough and began wheezing. When the stylist finished, the wheezing had stopped but the cough remained, and now Jane had a headache and an irritated throat.

By the following day, Jane still had a harsh cough and went to a nearby urgent care clinic. She told the doctor that she was in excellent health, had no known allergies, no medical conditions, and wasn’t taking any prescription medications or dietary supplements. Her only regular OTC medicine is a multivitamin product, SuperGood, two capsules daily. The doctor examined her and listened to her lungs and heart. He said everything was normal, but suggested that Jane think about reporting her reaction to the FDA. Jane returned home and her cough went away after 3 days and has not returned.

Jane decided to go back to the salon and asked for information on the straightening product used. The product used was XYZ Pharmaceutical’s hair straightener, salon strength, made in Texas.

Section A – About the Problem

What kind of problem was it? (Check all that apply)

Did any of the following happen? (Check all that apply)



For a problem with a product, including

  • prescription or over-the-counter medicine
  • biologics, such as human cells and tissues used for transplantation (for example, tendons, ligaments and bone) and gene therapies
  • nutrition products, such as vitamins and minerals, herbal remedies, infant formulas, and medical foods
  • tobacco and nicotine products, including those to help you quit
  • cosmetics or make-up products
Go to Section B

For problems with a medical device, including

  • any health-related test, tool, or piece of equipment
  • health-related kits, such as glucose monitoring kits or blood pressure cuffs
  • implants, such as breast implants, pacemakers, or catheters
  • other consumer health products, such as contact lenses, hearing aids, and breast pumps
Go to Section C
(Skip Section B)
Section B – About the Product
Did the problem stop after the person reduced the dose or stopped taking or using the product?
Did the problem return if the person started taking or using the product again?
Do you still have the product in case we need to evaluate it? (Do not send the product to FDA.
We will contact you directly if we need it.)
Go to Section D (skip section C)
Section C – About the Medical Device
Was someone operating the medical device when the problem occurred?
If yes, who was using it?

For implanted medical devices ONLY (such as pacemakers, breast implants, etc.):

Go to Section D
Section D – About the Person Who Had the Problem
Sex
Go to Section E
Section E – About the Person Filling Out This Form

We will contact you only if we need additional information. Your name will not be given out to the public.

Did you report this problem to the company that makes the product (the manufacturer)?
May we give your name and contact information to the company that makes the product (manufacturer) to help them evaluate the product?
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