Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4505

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2022_026762

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.

16-JUN-22

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

23-MAY-22

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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Large Dog Collar

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

---

7. b) Type of formulation.

Other (specify)

collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 16 Jun 2022, Elanco was contacted by an animal owner regarding a potential adverse event and death involving a Seresto (imidacloprid+flumethrin) Large Dog Collar in a dog and reported the following: Since an unknown date, the dog has received regular topical application of Seresto (imidacloprid+flumethrin) Large Dog Collars without incident. On 02 Apr 2022, the dog received topical application (around the neck) of a new Seresto (imidacloprid+flumethrin) Large Dog Collar for flea/tick control, by the animal owner. Product was used correctly.

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

American Pit Bull Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

39.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Loss of appetite
  • Symptom - Vomiting
  • Symptom - Diarrhea
  • Symptom - Weight loss

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Vocalizing
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Anorexia

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

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

The 5-year-old, neutered male, 39.5 Kg, American Pit Bull Terrier, in unknown condition (reported as healthy by the animal owner), had no known concomitant medical conditions. Concomitant medication include ivermectin based monthly heartworm preventative. The dog was also up-to-date on routine vaccines (vaccine brands and antigens were not specified). On 23 May 2022, the dog experienced not eating, vomiting, diarrhea, and weight loss. The animal owner implemented treatment with an electrolyte beverage. On 26 May 2022, the above signs continued, the dog experienced 2 seizures (no prior history of seizures), which lasted a couple of minutes (estimated as 2 minutes), the dog vocalized, then died. Per the animal owner the dog weighed only 15 kg at the time of death. The dog was buried by the animal owner. No veterinary intervention was sought.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here