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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0774

2. Registrant Information.

Registrant Reference Number: 180213921

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.

23-DEC-18

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

23-DEC-18

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. 31986      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution For Dogs Between 11 And 25 kg

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.75

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 December 22, 2018, the owner applied the product to the dog to treat a condition. The owner applied approximately 1.75 milliliters (mL) of the 2.5 mL tube.

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

Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

20.0

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
    • Symptom - Vocalizing

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

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 the morning of December 23, 2018, the dog developed symptoms. The owner then contacted the Animal Product Safety Service (APSS). The APSS assistant recommended the owner take the dog to a veterinarian, give the dog a bath (with liquid dish washing detergent (LDWD)), have the veterinarian call for information, and to call back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS assistant stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On December 26, 2018, the owner contacted the APSS to follow up on the case. The owner stated that the dog was given a bath at an unknown date and time and was fully recovered on the evening of December 25, 2018.