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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5308

2. Registrant Information.

Registrant Reference Number: 34163

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.

06-AUG-20

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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)

PMRA Registration No. 27586      PMRA Submission No.       EPA Registration No.

Product Name: advantage II large cat

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

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 5-Aug-2020, a 8 year old, 5.2 kg, female spayed in good condition with flea allergy dermatitis was administered one ADVANTAGE II 2 X 0.8 ML LARGE CAT, (-), by Animal owner. The product was used according to label (Yes).

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

Medical Professional

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 )

8

7. Weight (provide a range if necessary )

5.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Foaming at mouth
  • Nervous and Muscular Systems
    • Symptom - Trembling

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

Unknown/Inconnu

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

After application, the cat started to foam at the mouth, and started trembling. Two hours after application, the cat was brought into the clinic. Upon examination it was found to still be trembling, but was no longer foaming at the mouth. The cat was treated with Methacarbamol, and sent home. The outcome is unknown. Please note that this product was purchased from Amazon, and the seller of the product is unknown at this time.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here