Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2023-5525

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001338

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.

06-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-JUN-23

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 6 Jul 2023 the animal owner contacted Elanco regarding a possible adverse effect of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 20 (Imidacloprid, Moxidectin) in a dog and reported: On 30-May-2023 a dog was administered K9 Advantix II Medium Dog. On 08-Jun-2023 the owner administered Advantage Multi 20 to the dog. On 30-Jun-2023 the owner administered K9 Advantix II Medium Dog at 9:30 am. Update: On 08-Sep-2023 the animal owner contacted Elanco regarding a possible adverse event of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning the dog. On 30-Jul-2023 the dog was administered 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by owner followed by Vit E oil. On 15-Aug-2023 the owner administered Advantage Multi 20 (Imidacloprid, Moxidectin) topically by animal owner. On 08-Sep-2023, the dog was administered 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Terrier - Yorkshire

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

5.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Respiratory System
  • Symptom - Heavy breathing

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite

• Respiratory System
  • Symptom - Coughing

• Gastrointestinal System
  • Symptom - Other
  • Specify - Foreign body

• Nervous and Muscular Systems
  • Symptom - Agitation

• Respiratory System
  • Symptom - Other
  • Specify - Hyperpnea

• General
  • Symptom - Sleepiness

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 08-Jun-2023, in the evening, the 3-year-old, 5.5 kg, neutered, male, Yorkshire Terrier dog, was deep breathing. On 09-Jun-2023 the dog had returned to normal. On 30-Jun-2023 at 1:30 pm, the owner noticed the dog was lethargic, sleeping a lot (lethargy), and had decreased appetite. On 01-Jul-2023 the dog began to cough. On 03-Jul-2023 the cough was resolved. On 06-Jul-2023 the dog recovered. The owner spoke with the veterinarian who considered the cough could be due to poor environmental air quality, however, no veterinary examination was performed. On 30-Aug-2023 the dog was admitted to hospital with a foreign body lodged in his throat. FB was removed endoscopically. On 07-Sep-2023 the dog was bathed and clipped. On 08-Sep-2023, 1 hour following application the dog became agitated. The owner then applied Vit E oil to application site as previously suggest. Contacted owner 1.5 hours later, the dog seems settled and more comfortable.

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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