Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2218

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2024_009417

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.

09-MAR-24

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

09-MAR-24

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. 11556-133

Product Name: K9 Advantix Medium Dog

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 09 Mar 2024, Elanco received a communication from an animal owner regarding an adverse event involving K9 Advantix Medium Dog on a canine. On 09 Mar 2024, 1 tube/pipette of K9 Advantix Medium Dog was administeredto a canine topically by the animal owner for flea control. This product has been used sporadically on this pet since approximately 2022 with no issues.

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

Maltese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Diarrhea

• General
  • Symptom - Pacing
  • Symptom - Polydipsia

• Skin
  • Symptom - Red skin

• Eye
  • Symptom - Glazed eye

• General
  • Symptom - Listless
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 09 Mar 2024, 30 minutes post application, the 16-year-old, neutered male, Maltese dog, of an unknown weight and reproductive status, in unknown condition, with unknown concomitant medical conditions, exhibited diarrhoea, reddening of the skin, drinking a lot, and pacing. The canine was not examined by a veterinarian. The canine was bathed with baby shampoo and few times with a liquid dish soap and dried him off. On 10 Mar 2024 morning, the dog was listless, and his eyes were glazed over. On 10 Mar 2024 at approximately 9:30am, the pet died at home. Veterinarian attention was not sought, and owner plans to have the pet cremated.

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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