Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4735

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_032995

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.

27-JUN-23

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

02-JUN-18

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 Large Dog 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 27 Jun 2023, Elanco was contacted by an animal owner regarding Seresto. On approximately 01-Jun-2018, a dog had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner for flea control. The product was used correctly, and no concomitant products were used. The product was used previously years ago without issue.

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

Retriever - Labrador crossbred dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

21.3

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Parasitism

• Gastrointestinal System
  • Symptom - Vomiting

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

On approximately 02 Jun 2018, the 7-year-old, 21.3 kg, female, Retriever - Labrador crossbred dog, of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, had live fleas. On approximately 03 Jun 2018, the dog developed emesis. On approximately 08 Jun 2018, the Seresto Large Dog (Flumethrin-Imidacloprid) collar was removed. On approximately 10 Jun 2018, the emesis stopped without medical intervention, but the fleas continued. On approximately 27 Dec 2022, the dog died. No necropsy 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