Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6356

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2021_000876

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.

10-SEP-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-AUG-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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9 advantix II pipette size unknown

• 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.

Unknown

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 10 Sep 2021 a veterinarian contacted Elanco to report an adverse event to K9 advantix II pipette size unknown (Permethrin, Imidacloprid) in a canine/ dog.On an unknown date in 2021, a 19 month old, 36.6 kg, intact, female, Bulldog - American canine/dog, in unknown condition, with concomitant medical conditions of allergy/ skin issues, was administered 1 tube of K9 advantix II pipette size unknown (Permethrin, Imidacloprid) topically by the owner. The pet owner continued to treat the dog with the product monthly.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Bulldog - American

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.58

7. Weight (provide a range if necessary )

36.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Hair loss
  • Symptom - Other
  • Specify - Hair change

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 approximately 01 Aug 2021 the symptoms became noticeably worse. On 10 Sep 2021 the dog was seen by a veterinarian. It is unknown what treatments, if any were performed.

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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