Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5243

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2022_036936

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court

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.

28-JUL-22

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

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.       PMRA Submission No.       EPA Registration No. 11556-141

Product Name: K9 Advantix II Small Dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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7. b) Type of formulation.

Liquid

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 28Jul2022, an animal owner contacted Elanco to discuss product use for a new pet and mentioned an adverse event with the use of K9 Advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen). On approximately 01Jan 2017, a dog was on Interceptor Plus Chews 5.75 mg (milbemycin oxime, praziquantel) orally monthly until an unknown date. On an unknown date, the dog was administered 1 tube of K9 Advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the animal owner for parasite prevention. It was unknown if concomitant products were administered.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier / Miniature Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

5.4

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

• Skin
  • Symptom - Other
  • Specify - Tumors

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 an unknown date, the approximately 16 year old, approximately 5.4 kg, neutered, female, Yorkshire Terrier/ Miniature Poodle crossbred canine, in unknown condition, with no known concomitant medical conditions, developed tumors and died. It was unknown if the dog was examined by a veterinarian or if a necropsy examination was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here