Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-2604

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0015642 (Report 696166)

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-APR-21

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

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)

---

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

Product Name: Seresto large dog

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

---

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 unknown date in approximately 2020, a canine, of unknown signalment and condition, with concomitant medical conditions of fleas, had one Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Loss of appetite

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• General
  • Symptom - Death
  • Symptom - Neoplasia
  • Specify - Pancreatic cancer

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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 an unknown date post application, in approximately 2020, the canine developed tremors and loss of appetite. Approximately 8 months post application, in 2020, the collar was removed. Approximately 11 months post application, in 2020, the canine developed pancreatic cancer and died. No known necropsy was performed. No further information is expected. This case is closed.

---

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 Neurological signs such as tremors are not typically seen with appropriate topical product administration. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Reported loss of appetite is unspecific and may have numerous other causes. Sign may occur initially after collar administration but are not expected to appear after long time. However, time to onset is unknown. Reported pancreatic cancer and death is 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. Time to onset is exceptionally long. In this case, animal likely died due to pancreatic cancer. Moreover, pancreatic cancer and death occurred after long time of collar removal, thus not product related. Other unrelated causes are more probable. Overall, considering that many aspects in this case are unknown (e.g, animal details, use according to label, onset time for initial signs, if Veterinarian was consulted and necropsy results), a reasonable evaluation is not possible and a product relation is unassessable.