Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5454

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0049388 (Report 666819)

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.

22-SEP-20

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

26-MAY-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. 11556-152

Product Name: advantage II large cat

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

Units: mL

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 24-May-2020, a female, feline, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically 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

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

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?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • 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?

Yes

14. b) How long was the animal hospitalized?

4

Day(s) / Jour(s)

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 26-May-2020 the cat exhibited anorexia. On 29-May-2020 the cat was examined by a veterinarian. Bloodwork and radiographs were performed with unknown findings. The cat was treated with an unspecified anti-inflammatory medication, subcutaneous fluids, maropitant citrate injection, maropitant citrate tablets, cefovecin sodium injection, and prescription diet. On 25-Jun-2020 the cat exhibited adipsia and anorexia continued. The cat was seen by a veterinarian. Blood work was performed with unknown results. The cat was hospitalized and with intravenous fluids, cefovecin sodium injection, mirataz transdermal ointment, doxycycline tablets. On 29-Jun-2020 the cat was discharged. On 01-Jul-2020 the cat died. No necropsy was performed. No more information is expected. 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 Anorexia and adipsia are unspecific and may have various other causes. Time to onset is long. Further reported death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Time to onset is long. Considering limited information such as medical history, animal details, health status and necropsy details, a product involvement is considered unassessable.