Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2825

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_001018 and CA2024_001019

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-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

15-APR-24

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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Small 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.

.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 15Apr2024, a pet owner contacted Elanco to report an adverse reaction with K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 14Apr2024, the pet owner applied 1 tube of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog. The product was used correctly. No concomitant products were administered. At the time of the application the cat in the house was separated from the dog. The pet owner was at a friend's home with 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

2

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

12. How long did the symptoms last?

<=30 min / <=30 min

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

Fully Recovered / Complètement rétabli

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 15Apr2024, 25 hours post application, the 1 year old, 2 kilogram, neutered female, Chihuahua in unknown condition with no concomitant medical conditions, vomited bile one time and then recovered without treatment. The dog was not examined by a veterinarian.

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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

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Sphynx

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

4.54

kg

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Anorexia

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

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify Possible physical contact with the treated dog

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 15Apr2024, 20 hours post application to the dog, the pet owner returned home, to the cat, with the dog. The pet owner left the home leaving the cat and dog together an hour later. On 15Apr202, 25 hours post application to the dog, upon the pet owner's return to the home, the pet owner noticed the cat had vomited several times and was anorexic. It is unknown when the vomiting and anorexia started. It is unknown if the cat was in physical contact with the dog. The last time the cat vomited was 2 hours post onset. The vomiting resolved without treatment. On 16Apr2024 the anorexia resolved without treatment. The cat was not examined by a veterinarian. The veterinarian's suspicion that K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) has a causal association with the clinical signs is unknown.

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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