Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0367

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_037246

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.

11-NOV-21

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

11-OCT-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)

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

Product Name: Seresto Cat Collar

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

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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 11 Nov 2021, Elanco was contacted by an animal owner regarding general product use and inadvertently reported a lack of efficacy and adverse event. On approximately 11 Jun 2021, the cat had 1 Seresto Cat collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner for flea control.

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

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Hyperactivity

• Skin
  • Symptom - Hair loss
  • Symptom - Other
  • Specify - Hair change (Hair separated from skin)

12. How long did the symptoms last?

Persisted until death

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

On approximately 11 Oct 2021, the 11 year old, female, cat, in unknown condition, with no known concomitant medical conditions, developed application site hair loss, application site hair change (hair separated from skin), anorexia, and hyperactivity (jumping down from unknown surface). The cat was evaluated by a veterinarian, no known treatment was performed. On approximately 13 Oct 2021, the cat passed away.

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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