Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4123

2. Registrant Information.

Registrant Reference Number: 2023-CA-000120

Registrant Name (Full Legal Name no abbreviations): Evergreen Animal Health, LLC

Address: 22655 Centennial Road

City: Gretna

Prov / State: Nebraska

Country: USA

Postal Code: 68028

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

Domestic Animal

4. Date registrant was first informed of the incident.

21-APR-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

19-APR-23

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. 33791      PMRA Submission No.       EPA Registration No.

Product Name: Parapet K9 Praventa 360 for Medium Dogs 4.6-11kg, 6 Tubes

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

Please refer to field 13 on Subform II or field 17 of Subform III for a detailed description regarding application.

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

Dog / Chien

3. Breed

Bichon Frise/Poodle crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

5.9

kg

8. Route(s) of exposure

Skin

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

• General
  • Symptom - Discomfort

• Nervous and Muscular Systems
  • Symptom - Agitation

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

On 19-Apr-2023, a 1 year old, 5.9 kilogram, neutered, female, Bichon Frise/Poodle (Unspecified) dog, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Parapet K9 Praventa 360 for Medium Dogs 4.6-11kg, 6 Tubes (Imidacloprid, Permethrin, Pyriproxyfen) via the topical route by the animal owner. Approximately 1 hour post application, the dog developed agitation and acted uncomfortable (discomfort). On 20-Apr-2023, the dog was bathed with an unspecified dog shampoo by the animal owner. On 21-Apr-2023 the signs continued. The dog had not been evaluated by a veterinarian and no treatments were performed. The owner was advised to bathe the dog with liquid dish soap for product removal, and apply vitamin E oil and a cool compress to the application site. This was a first time use of the product. No further information was received.

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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

The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.