Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0922

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_042724

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L59 0C9

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

17-DEC-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)

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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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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: ROUNDUP (UNSPECIFIED FORMULATION)

• Active Ingredient(s)

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7. b) Type of formulation.

Liquid

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 17 Dec 2021, Elanco was contacted by an animal owner regarding a potential adverse event involving Advantage II (imidacloprid/pyriproxyfen) for large cats. The cat has received Advantage II Large Cat (imidacloprid/pyriproxyfen) since 2010 for treatment for fleas and lice. The owner mentioned she gave the cat gabapentin to calm her when they would go to the veterinary clinic but no other time. The owner said that in 2016 they moved into a house where the landlord had sprayed a pesticide for bedbugs and the owner could smell the product (Roundup). No EPA number or specific formulation of the product was mentioned just the brand name 'Roundup'.

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

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

4.53

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

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Malaise
  • Symptom - Vocalizing
  • Symptom - Neoplasia
  • Symptom - Cancer

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?

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 in 2016, her cat was not feeling well (coded as malaise) and was vomiting. On an unspecified date in 2019, the cat was crying out and was taken to the clinic and diagnosed with large cell gastric lymphoma and was placed on an unspecified steroid (owner declined chemotherapy for the cat). The cat passed away on approximately 24 or 25 May 2019. The owner was not attributing clinical signs to the product (incidental mention). The owner attributes the clinical signs to the non Elanco pesticide used for the bedbugs (Roundup).

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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