Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4880

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001044

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

City: Mississauga

Prov / State: Ontario

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.

06-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

03-JUN-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. 31517      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Kitten

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.23

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 06-Jun-2023, a pet owner contacted Elanco to report a possible adverse event regarding Advantage II Kitten (Imidacloprid, Pyriproxyfen) concerning a cat. On 01-May-2023, a cat was administered 1 tube of Advantage II Kitten (Imidacloprid, Pyriproxyfen) topically by the owner. On 03-Jun-2023 the cat was administered 1 tube of Advantage II Kitten (Imidacloprid, Pyriproxyfen).

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

Cat / Chat

3. Breed

Domestic short hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Respiratory distress

• Nervous and Muscular Systems
  • Symptom - Collapse

• Gastrointestinal System
  • Symptom - Fecal incontinence

• Renal System
  • Symptom - Urinary incontinence

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Limp

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

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 03-Jun-2023, 4 hours following the application of Advantage II, the male Domestic Shorthair cat, of unknown reproductive status, weight and age, in unknown condition, with no known concomitant medical conditions, was found to be limp (collapse), urinated (urinary incontinence) and defecated (fecal incontinence), then began agonal breathing (respiratory distress), then died. The animal was not examined by a veterinarian. On 06-Jun-2023 the cat was submitted for necropsy.

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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