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: 2017-7003

2. Registrant Information.

Registrant Reference Number: 170131013

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.

31-JUL-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

31-JUL-17

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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

PMRA Registration No. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Over 14 kg (30 lbs)

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 July 30, 2017 the owner bathed the dog with the shampoo product to treat a condition. When the dog was dry, the owner applied 2.0 milliliter (mL) of the spot on product to treat a condition.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

45.0

lbs

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

  • Gastrointestinal System
    • Symptom - Vomiting
  • Renal System
    • Symptom - Anuria
    • Specify - Not Urinating
  • Gastrointestinal System
    • Symptom - Constipation
    • Specify - Absent Bowl Movements

12. How long did the symptoms last?

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

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

In the early morning hours of July 31, 2017 the dog had three isolated events of vomiting. Shortly after, the owner rinsed the dog off with water. Several hours later, the owner noticed the dog hadn't urinated or defecated all morning. The owner then contacted the Animal Product Safety Service (APSS). The APSS technician stated that shampoo, if licked, may cause mild self-limiting gastrointestinal (GI) upset. The APSS veterinarian noted for the spot on that permethrin is a pyrethroid and that dogs tolerate pyrethroids well. The APSS veterinarian also stated that no life threatening signs are expected. Finally the APSS veterinarian stated that methoprene is an insect growth regulator (IGR) with a wide margin of safety. The APSS assistant recommended the owner provide the dog with light exercise (want to see if the pet urinated, if so what color was it, was he straining, dribbling out, steady flow), monitor at home, monitor for GI signs (vomiting, diarrhea), 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 veterinarian stated that the substances were considered to have a doubtful likelihood of causing the clinical situation. Soon after, the owner called back to inform the APSS technician that the dog is normal and urinated normally. The APSS technician recommended the owner continue to monitor at home and to call back with questions if any more signs develop.