Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2289

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000742

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.

18-MAR-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

14-MAR-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. 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 18 Mar 2024, a veterinary technician contacted Elanco to report a possible adverse reaction in a canine that had been treated with Advantage Multi 20 and K9 Advantix II Medium Dog. On 12 Mar 2024, the dog was treated for the first time with one tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen), topically administered by the pet owner for ectoparasite prevention. On 14 Mar 2024, the dog was treated for the first time with one tube of Advantage Multi 20 (Imidacloprid, Moxidectin), topically administered by the pet owner for parasite prevention.

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

Boston Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.25

7. Weight (provide a range if necessary )

8.3

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Salivating excessively
  • Symptom - Diarrhea
  • Symptom - Abdominal distension
  • Specify - Flatulence

12. How long did the symptoms last?

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

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

On 14 Mar 2024, the 2.25 year old, 8.3kg, neutered female, Boston Terrier dog in fair condition, with pre-existing allergies and a history of surgery for an intussusception, experienced hypersalivation, diarrhea, gas (flatulence) and urgency to defecate (diarrhea). On 15 Mar 2024, the patient was examined by the veterinarian and treatment consisted of a probiotic. On 16 Mar 2024, the patient had recovered from all signs.

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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