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: 2014-2262

2. Registrant Information.

Registrant Reference Number: 1-37188070

Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL

Address: 100 STONE ROAD WEST, SUITE 111

City: GUELPH

Prov / State: ON

Country: CANADA

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

22-MAY-14

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

08-MAY-14

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol PowerSpot Flea and Tick Control for Dogs over 14 kg

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

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).

Caller applied product on her dog 2 weeks ago.

To be determined by Registrant

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

Yes

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Headache
    • Symptom - Dizziness
  • Gastrointestinal System
    • Symptom - Stomachache
    • Specify - stomach upset
  • General
    • Symptom - Lightheadedness
  • Skin
    • Symptom - Erythema
  • General
    • Symptom - Sweating

4. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

Contact with treated area

What was the activity? Petting the dog

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

12. Time between exposure and onset of symptoms.

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

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Caller applied product on her dog 2 weeks ago and developed symptoms. More symptoms developed over last six days. Caller has not seen an MD.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Symptoms are not consistent with exposure to product. Recommended to seek medical advice.