Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6911

2. Registrant Information.

Registrant Reference Number: 31822

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.

04-DEC-19

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

Unknown

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II 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.

2.5

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).

n Mar-2019, a 7.5 year old, 14 kg, female spayed Soft-coated wheaton terrier Poodle cross in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 2.5 ML LGE DOG, KP0 CLN0 KP0 CG6S by Animal owner. The product was used according to label, this was the first time the patient was receiving this product.

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

Soft coated wheaton terrier x poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

14

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

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

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin
  • Symptom - Hair loss
  • Symptom - Red skin
  • Symptom - Lesion

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

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

Within 12 hours of application, the dog was itchy all over and rubbing up against the walls. A second dose was applied a few months later (exact date unknown). Within 12 hours of the application the dog was itchy all over and rubbing against the carpet and the walls. The dog had application site hair loss, application site redness and application site crusts. The patient was not treated. The outcome is recovered.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here