Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0447

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2021_001326

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

11-NOV-21

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

08-NOV-21

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. 27583      PMRA Submission No.       EPA Registration No. 11556-125

Product Name: Advantage II Medium 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.

1

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 11 Nov 2021 the pet owner contacted Elanco regarding a possible adverse effect of Advantage II Medium Dog (Imidacloprid, Pyriproxyfen) in a dog. The pet owner reported that on 8 Nov 2021 she purchased Advantage II from her veterinarian to treat the dog for fleas. The owner administered one tube topically to the dog the same day.

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

Dog / Chien

3. Breed

Pug

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.6

7. Weight (provide a range if necessary )

4.54

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Swelling

• Eye
  • Symptom - Other
  • Specify - Eyes closed

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 8 Nov 2021 the 7 month old, 4.54 kg, neutered, male, Pug dog's face became swollen which caused its eyes to be closed (facial swelling). The pet owner reported she sought a veterinary examination; the veterinarian told her the dog appeared normal and there was no treatment. On 11 Nov 2021 the pet owner said the dog was improving. The pet owner declined reporting any further information.

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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