Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-0465

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002632

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.

01-NOV-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-SEP-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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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: ZODIAC FLEA AND TICK SHAMPOO (UNSPECIFIED FORMULATION)

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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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 01-Nov-2023, a pet owner contacted Elanco to report a perceived lack of efficacy and adverse reaction regarding K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On approximately 10-May-2023, 10 Jun 2023, 10 Jul 2023, 10 Aug 2023,10 Sep 2023, and 10 Oct 2023 a dog was administered 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner along the dorsal midline.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred Schnauzer/ poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

9.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin

• General
  • Symptom - Parasitism

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

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

On 26-Sep-2023, the 10 year old, 9.8 kg, neutered, male, Schnauzer/Poodle crossbred dog, in unknown condition, with concomitant medical condition of history of allergies, was found to have a flea and was bathed with a flea and tick shampoo. On approximately 06-Oct-2023, the dog was itchy and the pet owner administered diphenhydramine daily. On 21-Oct-2023, hundreds of fleas were observed on the dog. The dog was bathed with flea shampoo and administered Capstar 11.4 mg tab. On 01-Nov-2023 the pet owner bathed dog with a flea and tick shampoo.

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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