Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1253

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_000065

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.

18-JAN-22

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

18-JAN-22

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. 27585      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Small Cat

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

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 18-Jan-2022 a pet owner reported to SCI an an adverse event concerning Advantage II Small Cat (Imidacloprid, Pyriproxyfen) involving a cat. On 18-Jan-2022, the cat was administered 1 tube of Advantage II Small Cat (Imidacloprid, Pyriproxyfen) topically by the pet owner. Owner confirmed it was applied too low where the cat was able to lick and able to ingest the product.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair cat

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

2.72

kg

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Foaming at mouth
  • Symptom - Oral hemorrhage
  • Symptom - Gagging
  • Symptom - Salivating excessively

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 18-Jan-2022 approximately 45 minutes after the application, the approximately 13 week old, approximately 2.72 kg, non-pregnant non-lactating, intact female, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, was able to lick the application site and ingested an unknown amount of Advantage II Small Cat and gagged and began to hypersalivated a bloody foam. She subsequently recovered that same day.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here