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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0142

2. Registrant Information.

Registrant Reference Number: 160140720

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-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

16-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. 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.

2.5

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 12, 2016 the owner applied the product onto the dog.

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

Dog / Chien

3. Breed

Shetland Sheepdog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

37.8

lbs

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

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 16, 2016 the dog had a seizure. On September 17, 2016 the dog had another seizure. On September 19, 2016 the dog developed vomiting. On September 20, 2016 the owner took the dog to the veterinarian, who started the dog on fluid therapy, before calling the Animal Product Safety Service (APSS). The attending veterinary technician stated this was the first time they have seen the dog, no other treatments have been started, and the dog is stable now. 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 advised the signs are not related to the product and recommended continuing treatment (diagnostic work up).


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A follow up was not performed, because see details (signs are not related).