Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0118

2. Registrant Information.

Registrant Reference Number: 1-42034675

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

Domestic Animal

4. Date registrant was first informed of the incident.

25-OCT-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 25739      PMRA Submission No.       EPA Registration No.

Product Name: Vetkem Siphotrol 1000 Double Action Premise Treatment

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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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).

Subject sprayed 2 cans of product in the home approximately on Sept 9th and Sept 16th. A third can was used on Sept 26th. Product was applied to treat fleas. Product did not work.

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.

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

• Skin
  • Symptom - Rash

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

Contact with treated area

What was the activity? Sat on carpet

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.

Skin

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.)

After the second application ( 1 week to 10 days later ) she sat on the carpet, clothed and she became symptomatic. She had to see a doctor, who prescribed a steroid and she has also taken antihistamines OTC. She is unable to sit, causing her to miss work and unable to swim, preventing her from training for lifeguard certification.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Exposure to dried treated areas not expected to result in physical reaction. Unknown square footage treated. Product may have been over used.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Respiratory System
  • Symptom - Respiratory distress

• General
  • Symptom - Hesitancy to move
  • Symptom - Cancer
  • Specify - Possible Cancer

• Nervous and Muscular Systems
  • Symptom - Difficulty walking

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Euthanised / Euthanasie

16. How was the animal exposed?

Other / Autre

specify Unknown

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On Sept 8th after the first application of the product) the dog had respiratory trouble and could not walk. Dog was taken to the vet who said that he could not determine the exact cause of the symptoms, but thought it might be cancer. The dog was euthanized on Sept 10th.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Specialist also stated regarding her pet's death, this is certainly not something expected with the use of the product. The amount of active ingredient in the product is just enough to be effective against the targeted insects. The product is designed to bond with carpet and upholstery fibers, so that, once dry, the risk of secondary transfer is quite minimal. However, sensitivities to these products can vary. Reaction determined to be inconsistent with product use.