Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2007-7932

2. Registrant Information.

Registrant Reference Number: GSK81082/A0688340A

Registrant Name (Full Legal Name no abbreviations): GlaxoSmithKline Consumer HealthCare Canada

Address: 2030 Bristol Circle

City: Oakville

Prov / State: ON

Country: Canada

Postal Code: L6H 5V2

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

16-OCT-07

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

30-SEP-07

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No. 14969      PMRA Submission No.       EPA Registration No.

Product Name: R+C II 142G Spray

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Sprayed furniture and inside of car. Used one treatment as per directions for use - sprayed from a distance of 20-25cm, 900cm squared area sprayed for 3 seconds.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Asthma

• Gastrointestinal System
  • Symptom - Gagging

• Respiratory System
  • Symptom - Coughing

• Nervous and Muscular Systems
  • Symptom - Headache

• Eye
  • Symptom - Red eye
  • Symptom - Swollen eye
  • Symptom - Other
  • Specify - runny eye

• Gastrointestinal System
  • Symptom - Vomiting

• Eye
  • Symptom - Tearing

• Gastrointestinal System
  • Symptom - Nausea
  • Symptom - Other
  • Specify - hard to eat

• Respiratory System
  • Symptom - Choking

• Skin
  • Symptom - Itchy skin

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

She sprayed all her furniture and her father's car, and she started having what she describes as being severe asthma attacks. She started vomiting because she was coughing so hard and her ""wind pipe was getting constricted"". Her eyes get watery, she also experiences gagging due to severe coughing spells, and intermittent severe headaches. She is also having a hard time to sleep because she keeps waking up coughing. She went to see her Doctor, and since she could not eat because of her condition, her Doctor put her on Ensure. No new treatment has been prescribed, she is using her usual asthma medication. She was on her couch when she first started experiencing these symptoms. She then went to her bedroom and experienced the same symptoms.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Status update:Follow up received on November 13, 2007. Symptoms have resolved. Patient indicated that she had been prescribed a stronger asthma inhaler and a specialist prescribed pills to stop the itching, an unspecified cream to treat the scabies and a stronger Symbicort turbohaler. The patient stated that her symptoms had resolved but the patient then contradicted herself. The patient commented that she still could not 'get it out' of her furniture, she threw out all her area rugs. The patient said she was very sick with daily asthma attacks, runny eyes, red and swollen eyes, vomiting, headaches, and finds it hard to eat. Jan 8, 2008 Received follow up information from patient's physician. Physician reported additional concurrent medical conditions of depression and smoking. On an unknown date, the patient used pyrethrin + piperonyl butoxide. In October 2007 the patient experienced a flare up of asthma, swelling eyes, and tearing, vomiting, nausea, and choking. The physician considered the events to be life threatening. At the time of reporting, the outcome of the events was unknown.