Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0117

2. Registrant Information.

Registrant Reference Number: 1-41908586

Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL

Address: 100 STONE ROAD WEST, SUITE 111

City: GUELPH

Prov / State: ON

Country: CANADA

Postal Code: N1G 5L3

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

Human

4. Date registrant was first informed of the incident.

16-SEP-15

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

12-SEP-15

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.       PMRA Submission No.       EPA Registration No. 2724-774-43591

Product Name: Mycodex Plus Environmental Control Aerosol Household Spray

• Active Ingredient(s)
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration 1 %
  • PERMETHRIN
    • Guarantee/concentration .2 %
  • PYRIPROXYFEN
    • Guarantee/concentration .015 %

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7. b) Type of formulation.

Other (specify)

Aerosol

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: can

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).

Entire can was used to treat the house and applicator did not leave the home after product was applied.

To be determined by Registrant

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

Unknown

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

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Nausea
  • Symptom - Vomiting
  • Symptom - Stomach pain
  • Specify - abdominal pain

• General
  • Symptom - Fever
  • Symptom - Joint pain
  • Symptom - Pain

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?

Yes

6. b) For how long?

Unknown

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 h

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.)

Caller is a pharmacist at a hospital who is doing research for a patient. The physician has a patient who may have been exposed to the Mycodex Spray. She does not know by which route, or when. On 9/12/2015, the patient presented to the hospital with symptoms. Patient applied product and did not leave the house after application. Symptoms developed 5 hours after. Patient admitted to hospital on 9/15/2015 for ongoing symptoms.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Inhalation of this product may lead to irritation of the eyes and upper respiratory tract as well as nausea, cough, headache, difficulty breathing, and shortness of breath. Nausea could progress to vomiting. After the product was used the patient should have vacated the house for several hours. Upon return, she should have ventilated the home for several hours. Removal of the patient from the fumes and ventilation of the house is usually all that is needed with a resp irritant. Symptoms usually resolve within the 30 minutes or so of being in fresh air. Should symptoms persist, adding portable fans until the odor has dissipated is recommended along with washing treated surfaces with an appropriate household cleaner. Patients who smoke or have underlying respiratory conditions may experience more pronounced symptoms that require medical attention. The initial nausea/vomiting may or may not have been related to the product; however, the subsequent symptoms are unlikely to be related to her exposure.