Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4977

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001189

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5N 0C9

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

Domestic Animal

4. Date registrant was first informed of the incident.

20-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Small 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 20 Jun 2023, the veterinary technician contacted Elanco regarding an adverse reaction involving a dog administered K9 Advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 20 (Imidacloprid, Moxidectin). On 15 Apr 2023 the owner administered the dog's first dose of K9 Advantix II Small Dog topically. On 15 May 2023 the owner administered the dog's second dose of K9 Advantix II Small Dog. On 1 Jun 2023 the owner administered the dog's first dose of Advantage Multi 20 topically. On 15 Jun 2023 the owner administered the dog's third dose of K9 Advantix II Small Dog. Both products have been discontinued in this 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

Maltese crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

5.2

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

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Shaking

• Skin
  • Symptom - Pruritus

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

Not recovered / Non 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

An unknown time after each application of K9 Advantix II and Advantage Multi, the 2.5 year old, 5.2 kg, neutered female Maltese crossbreed dog experienced shaking and scratched its body for one week after application. On 20 Jun 2023, the dog was currently experiencing these signs after the most recent application of K9 Advantix II. No veterinary examination or treatment had been sought.

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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