Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5238

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2022_036271

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.

26-JUL-22

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

01-MAR-22

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. 11556-151

Product Name: Advantage II Small Cat

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 26 Jul 2022, an animal owner contacted Elanco regarding adverse event with using Advantage II Small Cat on their cat and reported the following: On approximately 28 Feb 2022, a feline was administered 1 tube of Advantage II Small Cat (Imidacloprid, Pyriproxyfen) via the topical route by the animal owner for flea control. On 18 Jul 2022, the cat was administered 1 tube of Advantage II Small Cat (Imidacloprid, Pyriproxyfen) via the topical route by the animal owner for flea control.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

2.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Shortness of breath

• Gastrointestinal System
  • Symptom - Loss of appetite

• General
  • Symptom - Other
  • Specify - Herpesvirus

• Respiratory System
  • Symptom - Other
  • Specify - Agonal breathing

• General
  • Symptom - Death

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

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 01 Mar 2022, the 2-year-old, 2.2 kg, male/neutered, Domestic Shorthair feline, in unknown condition, with concomitant fleas, had shortness of breath, lethargy, and loss of appetite. The cat was examined by a veterinarian, the cat was diagnosed with herpes, administered intravenous fluids, and placed on unspecified eye drops. On approximately 01 Apr 2022, the cat had recovered. On 19 Jul 2022, the cat developed shortness of breath, lethargy, and loss of appetite. The cat was not evaluated by a veterinarian and the clinical signs continued. On 26 Jul 2022, the feline developed agonal breathing and died in route to the vet. No necropsy was performed.

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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