Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0959

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_042735

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5N 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. 11556-151

Product Name: Advantage II Small 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. 11556-116

Product Name: Advantage 9

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

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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, an animal owner contacted Elanco regarding an inquiry and mentioned a potential adverse event involving Advantage II Large Cat. On an unknown date in 2005, the cat, prior to 8 weeks of age, received Advantage 9 for treatment for fleas and lice. The frequency of administration was unknown. The owner mentioned she had bottle fed the kitten and it had not received colostrum from the mother and had preexisting upper respiratory issues. On an unknown date in approximately 2010, the cat was administered Advantage II Small Cat. The frequency of administration was unknown. On an unknown date in 2016, the cat began being administered Advantage II Large Cat. The frequency of administration was unknown. On an unknown date in 2016, the owner moved into a house where the landlord had sprayed a pesticide for bedbugs (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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown (Feline/cat)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

5.4

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 - Malaise

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Weight loss

• Cardiovascular System
  • Symptom - Heart murmur

• Eye
  • Symptom - Pupil dilation

• Renal System
  • Symptom - Renal failure

• Gastrointestinal System
  • Symptom - Loss of appetite

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Arthritis

• Respiratory System
  • Symptom - Pleural effusion

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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, the owner gave the cat gabapentin to calm him when they would go to the veterinary clinic but no other time. On an unknown date in Aug 2016, the 11 year old, 5.0 - 5.4 kg, neutered, male, unknown breed cat was not feeling well and was vomiting. On approximately 01 Aug 2020 the cat was losing weight and went to the clinic (weighed 3.40 kg) and was diagnosed with a heart murmur. The blood work showed the beginning of renal failure and the cat was placed on a urinary tract diet. On an unknown date approximately Jan 2021 the cat's renal blood work looked better but was showing stage 2 kidney failure. On an unknown date in 2021, the cat was still losing weight and is pupils were dilated. On 27 Apr 2021 the cat's appetite had decreased and he went to the clinic and was diagnosed with arthritis and an abdominal ultrasound showed fluid outside of his lungs and he had lost another 5 pounds. On 08 May 2021, the cat stopped eating and was 2.72 kg and passed away. The owner was not attributing clinical signs to the product (incidental mention). Owner was attributing clinical signs to non Elanco pesticide.

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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