Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5735

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2023_038183

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.

21-JUL-23

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. 11556-151

Product Name: Advantage II Small Cat

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 21 Jul 2023, an animal owner contacted Elanco regarding an adverse event involving the Advantage II Small cat in their cat and reported the following: On 07 Jul 2023, a cat was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner for flea control. The product was used for the first time. It is unknown whether any concomitants were administered.

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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Other
  • Specify - Abdominal effusion positive for bacteria

• Skin
  • Symptom - Discolouration
  • Specify - Hair discoloration
  • Symptom - Hair loss
  • Symptom - Other
  • Specify - Skin texture change

• General
  • Symptom - Adipsia
  • Specify - Decreased water intake

• Gastrointestinal System
  • Symptom - Abdominal distension

• General
  • Symptom - Hiding

• Gastrointestinal System
  • Symptom - Loss of appetite

• General
  • Symptom - Weakness
  • Symptom - Other
  • Specify - Systems compromised

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

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, a few days after application of Advantage II, the 10-year-old, unknown weight, neutered, male, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, experienced fur whitening (hair discoloration) at the application site, and then the hair fell out (hair loss). The cat's skin appeared to have a different texture at application site (skin texture change) but there were no open wounds or scabs. The cat also stopped eating (loss of appetite) and has only been drinking small amounts (decreased water intake). His abdomen appeared swollen (abdominal distension), and he had been hiding. On 17 Jul 2023, the animal owner took cat to veterinarian, and they performed an x-ray and abdominocentesis. They found white fluid in the abdomen which was sent off for testing. The clinical signs continued. It is unknown whether any treatments given. On an unknown date, the abdominal fluid that was sent out on 17 Jul 2023 was found to have bacteria present. According to the owner, the veterinarian said this indicated that the cat's systems were compromised through factors unknown. The owner was told the cat needed surgery, but it was risky because the cat was so weak. No treatments were done. On approximately 26 Jul 2023, the cat passed away.

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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