Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-7139

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002614

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.

31-OCT-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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 31-Oct-2023 a veterinary clinic staff member contacted Elanco to report a possible adverse effect of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 55 (Imidacloprid, Moxidectin). On 19-Sep-2023, the dog was administered either 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) or 1 tube of Advantage Multi 55 (Imidacloprid, Moxidectin) topically by the owner, but the owner was not sure which product was applied on this date. On 20-Sep-2023 the dog was administered the other product which it did not receive the prior day, so either 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) or 1 tube of Advantage Multi 55 (Imidacloprid, Moxidectin) 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

French Bulldog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

9.3

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

Unknown / Inconnu

11. List all symptoms

System

• Renal System
  • Symptom - Urinary incontinence

• Skin
  • Symptom - Irritated skin
  • Symptom - Discolouration
  • Specify - Application site hair coat discolouration
  • Symptom - Red skin
  • Symptom - Hair loss
  • Symptom - Other
  • Specify - Aplication site hair change

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 19-Sep-2023, the 2-year-old, 9.3 kg, neutered male, French Bulldog canine, had 2 episodes of urinary incontinence that day. On 20-Sep-2023, the urinary incontinence resolved. On approximately 22-Sep-2023 the dog developed application site irritation and redness as well as application site hair loss and discoloured, brittle hair. On 01-Nov-2023 the application site irritation and redness was resolved.

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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