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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0161

2. Registrant Information.

Registrant Reference Number: 160139006

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.

16-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-SEP-16

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. 31984      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution for Cats Over 4 kg

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 September 8, 2016 the owner applied the product onto the cat for the first time.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

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 )

4.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Hiding
  • Gastrointestinal System
    • Symptom - Drooling

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 September 15, 2016 the cat developed inappetence and started hiding. On September 16, 2016 the cat developed hypersalivation. Later that evening, the owner took the cat to the veterinarian. The attending veterinarian then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated imidacloprid is an insecticidal agent that has a wide margin of safety in mammals. The APSS veterinarian also stated it kills insects by binding to the nicotinic acetylcholine receptors in the insect nervous tissue, which are much more prevalent than in mammals. The APSS veterinarian finally stated risks. The APSS veterinarian recommended a diagnostic evaluation and supportive care as she would not expect any signs to develop this far post exposure.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. Signs are expected to be mild and self-limiting.