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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6052

2. Registrant Information.

Registrant Reference Number: 190086393

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.

20-MAY-19

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

19-MAY-19

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea And Tick Control For Dogs Under 14 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

20.0

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia

12. How long did the symptoms last?

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

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

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 May 19, 2019, the owner accidentally gave the dog 1.0 milliliter (mL) of this product orally, as prevention. Soon after, the dog became symptomatic. On May 20, 2019, the owner contacted the Animal Product Safety Service (APSS). The owner stated that the dog's ataxia was now resolved. The APSS assistant recommended the owner monitor at home and to call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

This was inappropriate use of the product, it is a topical and should never be given orally as stated on the instructions.