Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5759

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001458

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.

03-AUG-22

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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. 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 3 Aug 2022, the clinic's staff contacted Elanco regarding an adverse event in a dog treated with Advantage Multi 10 (moxidectin, imidacloprid) and K9 Advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 1 Jun 2021, the patient had been treated with a first dose of Advantage Multi and K9 Advantix II. Timing of both product applications is unconfirmed. On 01 Jul 2021, the dog was administered the products. In 2022, the first application of Advantage Multi was done on 16 Jul 2022. On 18 Jul 2022, K9 Advantix II was applied.

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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.6

7. Weight (provide a range if necessary )

1.7

kg

8. Route(s) of exposure

Skin

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 - Other
  • Specify - Gastroenteritis
  • Symptom - Diarrhea

• Nervous and Muscular Systems
  • Symptom - Muscle spasm
  • Symptom - Trembling

• Gastrointestinal System
  • Symptom - Other
  • Specify - Difficulty eating
  • Symptom - Other
  • Specify - Difficulty drinking
  • Symptom - Vomiting
  • Symptom - Bloody diarrhea
  • Symptom - Melena

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?

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

An unknown time after the 01Jun2021 application, the dog presented severe gastroenteritis (details not provided) and was treated at an emergency clinic (details unknown). Following the 01Jul2021 application of products, the dog presented diarrhea which resolved without treatment within a couple of days of each application. On an unknown date after the 16Jul2022 application, the 1.6 year old, 1.7 kg, spayed female, Yorkshire Terrier dog had no history of concomitant disease or medication, presented spasms, trembling and had difficulty eating or drinking. Trembling and spasms resolved although the feeding and drinking issues persisted. An unknown time after the 18 Jul 2022 application, the patient presented vomiting and diarrhea while the difficulty eating and drinking continued. The signs lasted 2 weeks. On 30 Jul 2022, the diarrhea was bloody and the stools were tarry (melena) and the dog was vomiting. The patient was examined on 4 Aug 2022. The examination was unremarkable and treatment with omeprazole was started. At the time of the last communication with the clinic, all signs had 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