Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2215

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_063038

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.

25-NOV-23

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

25-NOV-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.       PMRA Submission No.       EPA Registration No. 11556-142

Product Name: K9 Advantix II Medium Dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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7. b) Type of formulation.

Liquid

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 25 Nov 2023, Elanco was contacted by an animal owner regarding a possible adverse event when using K9 Advantix II Medium Dog and reported the following: On 25-Nov-2023, a dog was administered with 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) via a topical route by the animal owner for flea and tick prevention. K9 Advantix has been used on this pet monthly for many years on an unspecified date and had no reaction to the product in past. On 25 Nov 2023, the dog was also administered an unknown dose of Maropitant Citrate via an oral route, unknown of levothyroxine Sodium via an oral route, an unknown dose of Pimobendan via an oral route, omeprazole and prednisone via an oral route by the animal owner and by the animal owner. On 08 Mar 2024, the owner called Elanco with more information.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Havanese/Poodle (Unspecified) crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

17

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Shaking

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 25Nov2023, the owner reported the following to Elanco: On 25-Nov-2023, approximately 2 hours post application, the 17-year-old, 7.7 kg, neutered, male, Havanese/Poodle (Unspecified) crossbred dog, in an unknown condition, with concomitant medical conditions of Thyroid disease, unspecified gastrointestinal issues, and unspecified heart issues, began shaking. The pet was bathed by the owner and was resting comfortably. It was unknown what the pet was bathed with. Pet has a history of shaking episodes when he needs to be fed. Pet did have a medication change recently so pet owner is trying to rule out the cause of symptoms. On 08Mar2024, the owner reporting the following to Elanco: On an unknown date, the dog died.

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To be determined by Registrant

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

Death

19. Provide supplemental information here