Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3078

2. Registrant Information.

Registrant Reference Number: 2015CK086

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Boulevard

City: Missisaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

26-MAY-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

25-MAY-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. 27583      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II medium

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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).

a 5kg shih tzu x 18month FS was treated with dolpac with food and treated with topical advantage II medium concurrently by the pet owner on may 25th 2015.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

cross breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Pale mucous membrane colour

• Nervous and Muscular Systems
  • Symptom - Shaking

• Cardiovascular System
  • Symptom - Abnormally slow heart rate

• General
  • Symptom - Hypothermia

• Nervous and Muscular Systems
  • Symptom - Collapse

12. How long did the symptoms last?

<=30 min / <=30 min

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

12

Hour(s) / Heure(s)

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

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

10 minutes later, the dog vomited up the dolpac tablet. the dog continued to profusely vomit and 15 minutes later started shaking and collapsed. the dog was taken to the vet clinic (v. close by). very pale gums, temp 37. HR 40bpm. the dog was treated with aggressive iv fluids, oxygen, diphenhydramine and was bathed. The dog was recovered within 30 minutes.this dog has received advantage previously without any adverse event. the reporter did not think that the advantage cause the signs since the dog has received advantage previously without problems

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here