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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6651

2. Registrant Information.

Registrant Reference Number: 170161154

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.

15-SEP-17

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

09-SEP-17

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)

PMRA Registration No. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Flea and Tick Spray For Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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).

On September 1, 2017 the owner applied the spray to the dog to treat a condition.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

48.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Respiratory System
    • Symptom - Coughing
  • Eye
    • Symptom - Discharge eye
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Seizure

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

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 September 9, 2017 the dog developed coughing. September 10, 2017 the dog developed ocular discharge and lethargy, and on September 14 2017 the dog developed seizures. Shortly after, the owner took the dog to the regular veterinarian who did a diagnostic evaluation, gave corticosteroid, gave an antibiotic, and managed the seizures. The owner notes that the regular veterinarian suspects distemper or meningitis. In the evening on September 15, 2017 the owner contacted the Animal Product Safety Service (APSS), whose veterinarian stated that the spray is well tolerated and that coughing and ocular discharge could be seen if the product was sprayed in the face, but signs would be seen shortly after exposure. The APSS assistant recommended that the owner continue to work with the regular veterinarian and to call back with questions.


To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. The owner stated that the dog's signs resolved on September 16, 2017 and that the dog is back to normal.