Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1097

2. Registrant Information.

Registrant Reference Number: 2023-CA-000472

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.

22-NOV-23

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

15-NOV-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, 3 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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Jack Russell Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

5.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Trembling
  • Symptom - Shaking

• Gastrointestinal System
  • Symptom - Bloating

• Nervous and Muscular Systems
  • Symptom - Head tilt

• Eye
  • Symptom - Nystagmus
  • Symptom - Corneal abrasion

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 14-Nov-2023, a 0.75 year old, approximately 5.0 kilogram, intact, female, Jack Russell Terrier dog, in unknown condition, with no known concomitant medical condition, was administered 0.5 tube of Parapet K9 Praventa 360 for Medium Dogs 4.6-11kg (Imidacloprid, Permethrin, Pyriproxyfen) via the topical route by the animal owner. This was an extra label use due to low dose being applied (partial tube). On 15-Nov-2023, the dog developed shaking, trembling, and lethargy. On 16-Nov-2023, the dog developed a head tilt and was brought to an emergency veterinarian for evaluation. The only abnormality noted on examination was a corneal scratch. The dog was prescribed meloxicam and unspecified eye drops and discharged. On 19-Nov-2023, the dog was bathed using an unspecified product. At some point between 16-Nov and 20-Nov-2023, the dog developed a bloated stomach. On 20-Nov-2023, the dog was taken to the primary veterinarian for evaluation and was started on intravenous fluids and an unspecified pain medication. Nystagmus was noted on exam. Unspecified blood tests and abdominal radiographs with barium contrast was performed. The radiographs revealed a possible gastrointestinal foreign body obstruction. Results of blood work were not provided. The dog was then transferred to an emergency veterinarian. Exploratory abdominal surgery was performed, but no gastrointestinal obstruction was identified. The dog remained hospitalized at the time of the report on 22-Nov-2023. Continuing therapies as advised by the attending veterinarian was recommended. No further information was received in this case.

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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: This product has a wide margin of safety in dogs when applied as per label directions. The active ingredients are poorly absorbed across intact skin so systemic signs are not anticipated. The dog was under-dosed in this case as only one-half tube was applied, making severe signs related to the product even less likely. The initial signs of lethargy and shaking may have been related to a paresthesia response. Signs of corneal abrasion, head tilt, nystagmus, and stomach bloating are not expected nor are they consistent with the toxicological profile of the product. Other causes must also be considered. 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.