Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1972

2. Registrant Information.

Registrant Reference Number: 2131854

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

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.

26-OCT-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-OCT-17

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: Vet-Kem Siphotrol 1000 Premise Spray

• 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).

Caller applied products to premises. After 10 minutes, the areas treated were cleaned. This was not proper use of the product.

To be determined by Registrant

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

No

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 - Irritated skin
  • Symptom - Pain
  • Symptom - Burning skin

4. How long did the symptoms last?

Unknown / Inconnu

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

No

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? Cleaning surface off of where the product was sprayed.

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?

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

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 was given directions from DVM to apply the product on the surfaces in her home and leave on for ten minutes, then she was instructed to clean the surfaces of where she applied the product. Caller stated that at some point after using the product, she had symptoms of a burning sensation on her skin and had washed her hands several times since the incident occurred. Safety Call Center explained that this product has a wide margin of safety to humans when exposed to it in this manner. Symptoms would be expected to resolve in a timely manner with no further symptoms expected to arise. Caller was advised to speak with her DVM on how she used the product. Also, if unexpected symptoms developed or if the symptoms were not improving or resolving as they had discussed, to contact the center anytime so they could advise on further treatment or determine if referral to a healthcare professional might be needed.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

This was an inappropriate use since the caller was not properly advised by the DVM on how to use this product. When treating home surface areas, the product should not have been touched until it was completely dry. Symptoms are expected to be mild and self-limiting.