Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0190

2. Registrant Information.

Registrant Reference Number: 160077219

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.

30-MAY-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

30-MAY-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. 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?

Yes

9. Application Rate.

1

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 May 29, 2016 the owner applied the product onto the dog for prevention.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Bichon Frise Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9.5

7. Weight (provide a range if necessary )

17.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • General
    • Symptom - Vocalizing
  • Skin
    • Symptom - Itchy skin
    • Specify - Rubbing Application Site
    • Symptom - Erythema

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 May 30, 2016 the dog developed agitation, vocalization, and rubbing of the application site. Later that morning the owner bathed the dog (with dog shampoo) and then contacted the Animal Product Safety Service. The APSS technician stated the risk is for dermal paraesthesia reaction and this is not expected to cause any systemic toxicity. The APSS technician recommended monitoring the dog at home, bathing the dog, applying vitamin E and a cold compress, and calling 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 technician stated that the substance was considered to have a high likelihood of causing the clinical situation. On May 31, 2016 the owner called the APSS back to confirm the product name. The owner stated the dog's agitation, vocalization, and rubbing of the application site had ended, but the dog had developed erythema. The APSS veterinarian again recommended applying vitamin E to the application site.