Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0080

2. Registrant Information.

Registrant Reference Number: 1-49650629

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.

09-SEP-17

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

08-SEP-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. 31986      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Infestop For Dogs 11 - 25KG

• Active Ingredient(s)
  • IMIDACLOPRID

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PMRA Registration No. 31984      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Infestop For Cats 4KG

• Active Ingredient(s)
  • IMIDACLOPRID

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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: Animal / Usage sur un animal domestique

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

On September 9th, 2017 the caller used the product and he is worried he got the product onto his skin and did not wash it off quickly.

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: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Irritated skin

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Headache
  • Specify - Headache and felt cold
  • Symptom - Other
  • Specify - felt cold

4. How long did the symptoms last?

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

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

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?

>8 hrs <= 24 hrs / >8 h <= 24 h

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.)

The caller used the product on September 8th 2017. For the rest of that evening he was symptomatic. He is worried that he got the product on his skin and did not wash it off quickly enough. He is also worried he may have put his hand in his mouth. When he called in on September 9th he was asymptomatic. The Propharma agent said the described exposure is not expected to result in a toxic concern as it has a low mammalian toxicity and binds at a higher affinity to insect receptors. Little to no Imidaclorprid is systemically absorbed via dermal exposure. The product can cause respiratory irritation that can manifest as nausea or a headache. The agent recommended the caller contact his doctor if symptoms develop again as the severity is not expected.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Signs were expected to be mild and self-limiting. This product was not used as per label. It is suggested to wear gloves when applying these products on to dogs or cats, after applying the product hands should be washed immediately.