Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0255

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2021_001179

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.

19-OCT-21

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

16-OCT-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. 29778      PMRA Submission No.       EPA Registration No. 11556-142

Product Name: K9 Advantix II Medium Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • 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 19-Oct-2021 Elano was made aware by the veterinary clinic regarding an adverse event involving K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a canine. On 16-Oct-2021, the dog, in unknown condition, with concomitant medical condition of arthritis, on concomitant medication meloxicam for arthritis, had 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) administered topically by the owner.

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

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

6.7

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

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Jaw disorder

• Eye
  • Symptom - Other
  • Specify - Lump

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Inability to open mouth

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

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 16-Oct-2021, the 10 year old, 6.7 kg, neutered, male, Mixed dog developed a lump over right eye and the inability to open mouth. On 19-Oct-2021 the canine/dog was examined by a veterinarian and was administered maropitant citrate via the injection route by the attending vet and On 19-Oct-2021 the canine/dog was also administered gabapentin orally by the owner. Dog has a prior history of the same reaction lump over eye and unable to open mouth when oral flea and tick medication (Nexgard Spectra and Simparica) has been administered in previous years. Outcome is unknown.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here