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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7143

2. Registrant Information.

Registrant Reference Number: 160132062

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.


5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.


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.


PMRA Registration No. 31985      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution for Dogs Over 25 kg

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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 August 26, 2016 the owner applied the product to the dog to treat for fleas. This was the first time the owner had used this product.

To be determined by Registrant

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


Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever Mix

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms


  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • General
    • Symptom - Polydipsia
    • Symptom - Pale mucous membrane colour
    • Symptom - Jaundice

12. How long did the symptoms last?

Unknown / Inconnu

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non 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 August 27, 2016 the dog developed symptoms. On August 29, 2016 the dog developed anorexia, vomiting, and polydipsia. On September 3, 2016 the dog developed pale mucous membrane color and icterus (do not know how severe this is). Later that day, the owner took the dog to the veterinarian, where a chemistry profile, complete blood count, radiographs were completed, and antibiotics (sent home) were prescribed. On September 4, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated imidacloprid is an insecticide that has a low toxicity to mammals. The APSS veterinarian also stated ingestion of this agent may cause mild gastrointestinal upset. The APSS veterinarian finally stated no observed effect level (NOEL) in dogs is 50 milligrams per kilogram (mg/kg). The APSS technician relayed to the owner the APSS veterinarian stated this product does not get absorbed systemically and we would not expect any organ damage from this product. The APSS technician recommended taking the dog back to the veterinarian (as signs are continuing), having the veterinarian call for information (we would like to speak with the veterinary clinic and discuss treatment with them), and calling back with questions.

To be determined by Registrant

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


19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 6, 2016 the owner returned the APSS's follow up call. The owner stated that the dog was still displaying all clinical signs and she had an appointment with the attending veterinarian that afternoon. The APSS technician asked that she either call the APSS back with an update or have the attending veterinarian call if they would like to discuss the case. At this time, no updates have been obtained.