Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-2335

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_000517

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.

15-APR-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-APR-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)

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PMRA Registration No. 29778      PMRA Submission No.       EPA Registration No.

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 15-Apr-2022 Elanco was made aware by pet owner through SCI of a possible adverse event pertaining to K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On 14-Apr-2022, the dog was administered 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) via the topical route by owner in several spots along the dorsal midline.

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

Bichon Frise

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.25

7. Weight (provide a range if necessary )

5.9

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour
  • Symptom - Hyperactivity
  • Symptom - Vocalizing

• Respiratory System
  • Symptom - Heavy breathing

• General
  • Symptom - Rubbing face

• Skin
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy
  • Symptom - Adipsia

• Nervous and Muscular Systems
  • Symptom - Agitation

• General
  • Symptom - Biting

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 14-Apr-2022 1 hour after application, the owner noticed the 15 month old, female, neutered, Bichon Frise, weighing 5.9 kg, in unknown condition, with no known concomitant medical conditions, was hyperactive/agitated and was digging at the sofa (abnormal behavior). She was also rubbing her back and face on the sofa and biting at her tail base (pruritus). On 15 Apr-2022 At 7 hours post admin (3am) the dog began breathing heavily. They bathed the dog first with Dawn dish soap, followed by another bath with a sensitive pet shampoo. The dog dog refused to eat and drink, was lethargic, continued to bite at her tail, and vocalized.

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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