Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5444

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0047298 (Report 664329)

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.

11-SEP-20

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

10-SEP-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 collar 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 08-Sep-2020, a 17 week old, 5.6 pound, intact, male, Domestic Shorthair feline, in unknown condition, with a concomitant medical condition of fleas, had one Seresto Cat (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?

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 )

0.325

7. Weight (provide a range if necessary )

2.54

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Oral hemorrhage

• Respiratory System
  • Symptom - Epistaxis
  • Symptom - Dyspnea

• Renal System
  • Symptom - Inappropriate urination

• General
  • Symptom - Death

• Unknown
  • Symptom - Other
  • Specify - Uncoded sign (Self-trapping in collar)

• Respiratory System
  • Symptom - Other
  • Specify - Gasping

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?

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 10-Sep-2020, the cat got the collar stuck in its mouth for an unknown amount of time. The cat exhibited bleeding from the mouth, inappropriate urination, dyspnea, epistaxis and gasping when found. The collar was removed. The cat was examined by a veter

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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

B - Possible Reported non-serious signs are related to the inappropriate collar position. Although not clearly stated, it is possible that collar application was too loose enabling the pet to move the collar in the inappropriate position. Signs consistent with incorrect collar position. However, further reported fatal outcome of death is not expected as inconsistent with product¿¿¿¿¿¿s pharmaco-toxicological profile. Nonetheless, the small collar has a predetermined breaking point. However, considering all aspects, a product relation is assessed as possible.