Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6886

2. Registrant Information.

Registrant Reference Number: 2018RB177

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

Address: 2920 Matheson Blvd

City: Mississaugua

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.

02-OCT-18

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

16-AUG-18

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: advantageII medium dog

• 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).

On 15 August 2018 the pet owner administered Advantage II medium to their 4.9 kg, female, crossbred dog. On 11 September 2018 the pet owner administered another dose of Advantage II medium to the same dog.

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

Crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

4.9

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Insomnia

• General
  • Symptom - Discomfort

• Nervous and Muscular Systems
  • Symptom - Anxiety

• Skin
  • Symptom - Hives

• General
  • Symptom - Malaise
  • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

On 16 August 2018 the dog suffered malaise and inactivity. The dog symptoms lasted 48 hours. On 12 September 2018 the dog experienced hives, anxiety, discomfort, and would not sleep. The dog also experienced vomiting for 2 days. The dog was treated by a veterinarian with subcutaneous fluids, cerenia (maropitant), diphenhydramine, dexamethasone, and prednisone. The outcome is unknown.

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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

O - Unclassifiable/unassessable Malaise is not expected following topical product application. Lethargy is unspecific and may be associated with malaise in this case. In individual cases hypersensitivity reactions such as hives to the product is possible in animals that are particular sensitive. Type IV allergy (delayed type hypersensitivity) can be excluded as first application of product. Reported anxiety, discomfort and not sleeping are unspecific and may have various other causes. Vomiting is not anticipated with appropriate topical product use. Oral ingestion of product was not observed. Even with oral product exposure sign would not be expected, but rather salivation. Though time to onset short for initial signs, it is long for later observed signs. Overall, a product involvement is considered as unassessable.