Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1816

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000284

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-FEB-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

09-FEB-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)

---

PMRA Registration No. 27585      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Small Cat

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

---

7. b) Type of formulation.

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 09-Feb-2024, a veterinarian contacted Elanco regarding a possible adverse reaction to Advantage II Small Cat (Imidacloprid, Pyriproxyfen) in a cat. On 07-Feb-2024 the pet owner applied the product to the cat.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

2.3

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Rectal hemorrhage
  • Symptom - Other
  • Specify - Intestinal hemorrhage

• General
  • Symptom - Neoplasia
  • Specify - Thyroid adenoma

• Renal System
  • Symptom - Other
  • Specify - Interstitial nephritis

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

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-Feb-2024, the 15 year old, 2.3kg, neutered, female cat, with an unknown medical history, was found deceased with blood around the anus. On 14-Feb-2024, a necropsy found signs of haemorrhage in the caecum and colon (intestinal haemorrhage), moderate chronic interstitial nephritis, and an adenoma on the thyroid.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here