Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0114

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_032491

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.

19-OCT-21

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

09-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 Small 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 19Oct2021, the pet owner called Elanco and reported the following: On approximately 15-Aug-2021, a dog with the concomitant medical condition of fleas, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

5.43

kg

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

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Blood
  • Symptom - Anemia

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy
  • Symptom - Parasitism

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 18-Aug-2021, a 4 year old, 5.43 kg intact, male, Shih Tzu dog, in unknown condition, no longer had fleas. On approximately 01Sep2021, the fleas returned. On approximately 09Oct2021, the dog was administered an unspecified multi-vitamin. This had previously been repeated daily for an unspecified number of years. The dog has been receiving a Capstar daily for the past 7 days and a topical flea spray (date estimated as 04 Oct 2021). The fleas continued. The dog developed lethargy and anorexia. On 11Oct2021, the dog was evaluated by the primary veterinarian who referred the dog to an emergent veterinarian. A complete blood count was performed, which showed that the dog was anemic. No treatments were performed and 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