Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2887

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_001197

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.

26-APR-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-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)

---

PMRA Registration No. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Small Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

---

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 26Apr2024, a pet owner contacted Elanco to report an adverse reaction with K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 12Apr2024, 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.

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

crossbred Maltese/ Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

3.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Disorientation

• Skin
  • Symptom - Lesion
  • Specify - Application site scab
  • Symptom - Pruritus

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 12Apr2024, immediately after application, the 4 year old, 3.2 kg, neutered male, crossbred Maltese/Yorkshire dog developed application site pruritus. On 15Apr2024 the dog was disoriented, the sign lasted 10 minutes, and the dog recovered without treatment. On 18Apr2024 the dog was seen by the veterinarian and kept at the veterinary clinic for a few hours for observation. No abnormalities were noted and no treatments were administered. Upon arriving home the dog became disoriented. The sign lasted 25 minutes and the dog recovered without treatment. On 19Apr2024, the dog was seen by the veterinarian. A full blood test and urinalysis was performed and the results were all within normal limits. The owner noticed an application site scab. The dog was not treated. The outcome of this case is unknown.

---

To be determined by Registrant

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

Moderate

19. Provide supplemental information here