Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5395

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0033165 (Report 649621)

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.

07-JUL-20

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

Unknown

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 collar large

• 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 an unspecified date in approximately 2018, a 9 year old, approximately 80 pound, neutered, male, Bloodhound dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On an unknown date post product application in approximately 2018, the collar was removed by the animal owner. On approximately 01-Jan-2020, a now 11 year old, approximately 80 pound, neutered, male, Bloodhound dog, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) 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

Bloodhound

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

36.287

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Other
  • Specify - Gastric torsion
  • Symptom - Other
  • Specify - Intestinal disorder NOS

• 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?

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 an unspecified date post product application in approximately 2018, the dog developed seizures . The dog was evaluated by a veterinarian. The dog was sent home on a treatment regimen of an unknown dose of an unspecified oral anti-seizure medication to be administered daily by the animal owner. On approximately 01-Jul-2020, the dog exhibited a gastric torsion and an intestinal blockage. The dog was administered an unspecified anesthetic by the veterinarian and the veterinarian performed abdominal surgery on the dog. Upon recovery, the dog died.

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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

O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures were reported in connection with product use in dogs. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Time to onset is unknown. Other causes must be considered in this dog with unknown health status and no seizure history. Further, it is not known whether seizures resolved. Later reported gastric torsion, intestinal blockage and death, after second collar application, are not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. Other unrelated causes are more probable. Death seems likely associated with digestive disorders, associated surgery and geriatric condition of the dog. Furthermore, the intent of the call was to inquire about product use in general and not to report this event. Considering all aspects and limited information, a product relation is unassessable.