Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2023-7142

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002413

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.

16-OCT-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

13-OCT-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. 27584      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Extra Large Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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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 16-Oct-2023, a clinic staff member contacted Elanco regarding a perceived lack of efficacy and a possible adverse reaction to Advantage II Extra-large Dog (Imidacloprid, Pyriproxyfen). On 26-Sep-2023 the pet owner applied the product to the dog.

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

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

35.45

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

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

11. List all symptoms

System

• Skin
  • Symptom - Erythema

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

On 13-Oct-2023 the 8 year old, 35.45kg, neutered, female, Golden Retriever dog, with concomitant fleas and generalized pruritus due to fleas, had reddening of the skin on her abdomen and thorax. On 16-Oct-2023 the pet owner reported still seeing fleas on the dog. Update On 11-Dec-2023 the pet owner contacted Elanco. On 10-Nov-2023 the pet owner bathed the dog with a dog shampoo. On 11-Dec-2023 the pet owner reports she is still seeing fleas and flea dirt on the dog. The dog has not been seen by a veterinarian to confirm the presence of fleas or flea dirt.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here