Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1025

2. Registrant Information.

Registrant Reference Number: 2021-CA-000201

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.

03-AUG-21

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

08-JUN-21

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. 33789      PMRA Submission No.       EPA Registration No.

Product Name: Parapet K9 Praventa 360 for Extra Large Dogs 25 kg or More

• 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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Siberian Husky and Labrador Retriever cross

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

27.2

kg

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Foaming at mouth

• Nervous and Muscular Systems
  • Symptom - Collapse
  • Symptom - Shaking
  • Symptom - Seizure

• Eye
  • Symptom - Pupil dilation

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

Yes

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 approximately 08-Jun-2021, a 12 year old, 27.2 kilogram, neutered, female, Siberian Husky and Labrador Retriever crossbred dog, in unknown condition, with a concomitant medical condition of decreased activity, was administered 1 tube of Parapet K9 Praventa 360 for Extra Large Dogs 25kg or More (Imidacloprid, Permethrin, Pyriproxyfen) via the oral route by the animal owner. The owner applied the dose of product to the dog's food. This was an extra label use as this product is not intended for oral administration. Approximately 4 hours post administration, the dog developed foaming at the mouth, collapsed, began shaking and exhibited a seizure, and had dilated pupils. The dog was immediately taken to a veterinary facility where is was evaluated and unknown treatments were performed. Approximately 4 hours after the onset of signs, the dog recovered and was discharged from the hospital. As of 03-Aug-2021, no further signs had occurred. No further information is expected.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Assessment: The product was misused in this case as it is labeled for topical application only. Ingestion generally only leads to oral or GI irritation. Neurological signs including collapse, dilated pupils, and seizures are not expected following ingestion of one dose of product however, individual sensitivities may exist. No discussion with the treating veterinarian occurred and the therapies provided are unknown. Other causes cannot be completely ruled-out. 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.