Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1598

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_000162

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-22

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

07-FEB-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)

---

PMRA Registration No. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Cat

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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-2022, a pet owner contacted Elanco regarding a product complaint and a perceived lack of efficacy following the application of Advantage II Large Cat (Imidacloprid, Pyriproxyfen). On 03-Feb-2022 the pet owner applied two drops from the vial of the product to the cat. The application was not performed according to label. On 09-Feb-2022 the pet owner once again applied two drops from the vial of the product to the cat. On 8-Mar-2022 pet owner contacted Elanco to let us know that he purchased a new box of Advantage II Large Cat (Imidacloprid, Pyriproxyfen) from Amazon. On 1-Mar-2022 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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic - Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

7

kg

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour
  • Symptom - Parasitism

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

Unknown/Inconnu

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

Product complaint, pet owner alleges that a change in formulation of the product is the cause of the perceived lack of efficacy. On 07Feb2022, 4 days after application the pet owner saw live fleas on the 7 year old, approximately 7kg, neutered, male, Domestic cat, in unknown condition, with concomitant medical condition of fleas. On 01-Mar-2022 after application the cat reacted in it's usual manner which was to run away after application. The symptom lasted 10-15 minutes and the cat recovered.

---

To be determined by Registrant

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

Minor

19. Provide supplemental information here