Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5405

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0037290 (Report 654083)

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.

25-JUL-20

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

05-JUL-20

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 cat

• 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 04-Jul-2020, an approximately 4 year old, approximately 3 pound, intact, male, Domestic Shorthair cat, in unknown condition, with concomitant medical conditions of fleas, had one Seresto Cat (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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

1.361

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Lesion
  • Symptom - Other
  • Specify - Application site Malodour

• Gastrointestinal System
  • Symptom - Difficulty swallowing
  • Symptom - Anorexia

• Skin
  • Symptom - Hair loss

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Drooling

• Skin
  • Symptom - Dermatitis

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 05Jul2020, the feline exhibited drooling, inappetance and difficulty swallowing. On an unspecified date in Jul2020, the feline exhibited an application site infection, application site sore, application site alopecia, application site malodor, an unspecified application foreign body and application site scabbing around the circumference of the neck. No medical treatment was sought. On 25Jul2020, the feline died. No necropsy was performed. No more information is expected. The case is closed.

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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 Reported inappetance and digestive disorders are unspecific and may have numerous other causes. Transient mild application site disorders may occur in sensitive animals after product application but the described application site infection, malodor and foreign body are not typically seen with product use. Time to onset is consistent. Malodour in this case may be linked to the reported other application site reactions. Further, 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Time to onset is long. Other causes should be considered. Overall, a product relation is considered unassessable.