Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2401

2. Registrant Information.

Registrant Reference Number: 29072

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.

16-MAY-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-MAY-19

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II extra large dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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-May-2019, a 3 year old, 34.1 kg, female spayed Labrador Retriever in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 4.0 ML EX LGE DOG, KP0D1ZF/ KP0CVJV (-), by Animal owner. The product was used according to label (Yes).

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

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

34.1

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Discomfort

• Skin
  • Symptom - Inflammation of the skin
  • Symptom - Irritated skin
  • Symptom - Itchy skin
  • Symptom - Red skin

• Nervous and Muscular Systems
  • Symptom - Restlessness

• General
  • Symptom - Abnormal behaviour
  • Specify - running and rolling on the ground

• Skin
  • Symptom - Hair loss

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

Within 30 minutes the dog became uncomfortable, had inflammed skin at the application site, was irritated, was scratching at the application site, developed application site reddening, was restless, and began running around and rolling on the ground. The pet owner bathed the dog and the symptoms continued. The dog was given Benadryl (diphenhydramine) and the symptoms continued. On 16 May 2019 the dog experienced hair loss at the application site. The dog was seen by a veterinarian who recommended bathing with a medicated shampoo, and administered dexamethasone. The dog was discharged with 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