Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-3253

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_000517

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.

07-APR-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

07-APR-23

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Medium 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.

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 7 Apr 2023, the veterinary clinic's staff contacted Elanco to report a suspected adverse reaction involving K9 Advantix II medium (Permethrin, Imidacloprid, Pyriproxyfen). On 7 Apr 2023, the pet owner applied one pipette of K9 Advantix II medium on her dog. No other medications were administered.

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

pug

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

7.7

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin

• Nervous and Muscular Systems
  • Symptom - Recumbent

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Hesitancy to move

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

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

On 7 Apr 2023, soon after application of K9 Advantix II, the 0.75 year old, 7.7 kg, intact male, Pug dog, with no known concomitant medical conditions, experienced intense itchiness. The dog then became reluctant to move and lied on its side. The dog refused to eat its meal. The clinic informed the owner that she should apply vitamin E around the application site and if that did not help, she could bathe the dog with a stripping shampoo, warning that there would be no left over product to protect the puppy if she opted for that treatment. The patient was examined at the clinic that day and had completely recovered.

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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