Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6361

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2021_000906

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

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

Domestic Animal

4. Date registrant was first informed of the incident.

15-SEP-21

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. 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 15 Sep 2021 Elanco was notified of an adverse event to K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog.On approximately 10-Nov-2020, a 6 year old, 7 kg, neutered, male, Poodle - Miniature canine/dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner.

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

Poodle - Miniature

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

7

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• Skin
  • Symptom - Pruritus
  • Symptom - Itchy skin
  • Symptom - Hyperesthesia

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?

Unknown

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

The dog began itching and scratching an unknow time after application. The dog was administered vitamin E. The symptoms persisted. The dog was also administered Advantage Multi 20 (Imidacloprid, Moxidectin) topically by the owner on an unknown date in November 2020. On unknown dates in December 2020 the dog was administered K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 20 (Imidacloprid, Moxidectin). An unknown time after application of the K9 Advantix II the dog became itchy and was scratching. The itching and scratching continued. On unknown dates in January, February, and March 2021 the dog was administered K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 20 (Imidacloprid, Moxidectin). An unknown time after application of the K9 Advantix II the dog became itchy and was scratching. The itching and scratching continued. On 10 Apr 2021 the dog was administered 1 tube K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) by animal owner. The dog became itchy and was scratching. The dog was given a bath. The dogs skin began to twitch. The symptoms persisted for 3 days. 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