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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7522

2. Registrant Information.

Registrant Reference Number: 160119305

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.


Prov / State: KENTUCKY

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.       PMRA Submission No.       EPA Registration No. 2724-404

Product Name: Zodiac Fleatrol Flea and Tick Spray for Dogs Cats Puppies and Kittens

  • Active Ingredient(s)
      • Guarantee/concentration .27 %
      • Guarantee/concentration .37 %
      • Guarantee/concentration .2 %

7. b) Type of formulation.


Application Information

8. Product was applied?


9. Application Rate.


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 9, 2016 the owner applied the product onto the dog for the first time to treat condition.

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

Cocker Spaniel

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

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

11. List all symptoms


  • Gastrointestinal System
    • Symptom - Constipation
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Weakness
  • Respiratory System
    • Symptom - Other
    • Specify - Gurgling
  • General
    • Symptom - Polydipsia
  • Nervous and Muscular Systems
    • Symptom - Stiffness
    • Symptom - Collapse
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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


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 10, 2016 the dog developed constipation. On August 11, 2016 the dog developed lethargy, anorexia, adipsia, ataxia, weakness, and gurgling. On August 12, 2016 the owner contacted the company, who attempted to transfer the owner to speak with the Animal Product Safety Service (APSS). The APSS veterinarian stated if overused may see alcohol toxicity, signs are expected within 12 hours or so. The APSS assistant did not provide treatment recommendations as the call had disconnected. The APSS assistant would have recommended a bland diet 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 August 13, 2016 the APSS assistant called the owner to follow-up. The owner stated the dog's constipation, lethargy, anorexia, adipsia, ataxia, and weakness all resolved earlier that morning. The owner stated the dog was drinking (water and chicken broth) and the dog did have a bowel movement and urinated that morning. The APSS assistant went over the treatment recommendations with the owner. The owner stated she was going to try the bland diet and call back with questions. Later that day, the owner called the APSS back to state the dog developed polydipsia, muscle stiffness, collapsed, and suddenly died. The APSS veterinarian recommended a necropsy and advised the owner to take the dog's body to the veterinarian so they could preserve the body. The APSS veterinarian told the owner not to bury the body and have the veterinarian call for necropsy instructions. On August 15, 2016 an APSS technician attempted to contact the owner to discuss the necropsy. After several attempts the owner finally answered and stated she decided not to go forward with the necropsy.