Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4528

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2022_029371

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-22

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

22-MAR-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 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 2022 a clinic staff member contacted Elanco regarding a potential adverse event with using Seresto Large Dog (Imidacloprid, Flumethrin) and Interceptor Plus Chews (milbemycin oxime, praziquantel) on their canine patient and reported the following: On an unspecified date in Dec2020, a dog had 1 Seresto Large Dog (Imidacloprid, Flumethrin), collar placed around the neck, by the owner for flea and tick control. The product was used correctly. The canine also received an unspecified dose of Interceptor Plus Chews (milbemycin oxime, praziquantel) orally monthly by the owner for heartworm prevention with the last dose in May2021.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Saint Bernard

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

50.3

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Lameness
  • Symptom - Other
  • Specify - Arthritis
  • Symptom - Anxiety

• Blood
  • Symptom - Anemia

• Skin
  • Symptom - Pale mucous membrane colour

• General
  • 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?

Unknown

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 22Mar2021, the 8 year old, 50.3 kg, neutered female, St Bernard canine, in unknown condition, with concomitant medical conditions of hip dysplasia, exhibited lameness and was examined by a veterinarian for arthritis concern. On 20Jun2021 the canine was examined by a veterinarian for anxiety concern and started on gabapentin trazadone .On 01Jul2021 the canine was started on acepromazine. On 09Jul2021, the canine was examined by a veterinarian and diagnosed with immune mediated hemolytic anemia and was started on prednisone. On 20Jul2021 the canine was started on phenylpropanolamine. On 29Jul2021 records indicated that the anemia was controlled and resolving. On17Aug2021, the canine was examined by a veterinarian because the owner was concerned the dog's membranes were pale, on exam they appeared normal and the canine was treated with maropitant citrate. On 21Aug2021 the canine was found dead at home. No necropsy was performed and the remains were cremated.

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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