Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0110

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_031291

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

13-OCT-21

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

01-SEP-21

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 Small 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 13-Oct-2021, Elanco was contacted by an animal owner to report the passing of her cat and a potential lack of efficacy with the use of a Seresto Small Dog collar on her cat. On 30-Aug-2021, the cat had 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. This was an extra label use of the product due to species.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Other
  • Specify - Weight gain

• Skin
  • Symptom - Hair loss
  • Symptom - Erythema
  • Symptom - Bleeding
  • Symptom - Other
  • Specify - Mucopurulent discharge

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Parasitism
  • Specify - Tick-borne disease
  • Symptom - Death

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?

3

Day(s) / Jour(s)

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 01-Sep-2021, the 1 year old, approximately 10 pound, intact, male, Domestic Shorthair cat, in unknown condition, with concomitant medical condition of being underweight, exhibited weight gain. On 07-Sep-2021, the cat developed application site hair loss, application site erythema, application site bleeding and application site mucopurulent discharge. On 10-Sep-2021 the cat presented to the veterinarian for a routine neuter. The veterinarian recommended collar removal, which was performed by the animal owner. The cat was administered an unknown dose of an unspecified antibiotic injection via the unknown route by the veterinarian. On 11-Sep-2021, the cat exhibited anorexia. On 13-Sep-2021, the cat was evaluated by the veterinarian and unknown blood work was performed that revealed an unknown tick-borne disease. The cat was hospitalized and unknown treatments were performed. On 16-Sep-2021, the cat died while still hospitalized.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here