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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0004

2. Registrant Information.

Registrant Reference Number: 140142373

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.

09-NOV-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-NOV-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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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 October 8, 2014 the owner applied a tick collar onto the dog and removed it on November 8, 2014 before bathing the dog with the Zodiac shampoo. The owner put the same tick collar back onto the dog after the bath.

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

English Springer Spaniel

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

50.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Specify - Hind Limb Weakness
    • Symptom - Difficulty walking
  • General
    • Symptom - Vocalizing

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 November 8, 2014 the dog became symptomatic. On November 9, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS assistant recommended taking the dog to the veterinarian, having the veterinarian call for information, and calling back with questions.


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 Zodiac shampoo was considered to have a doubtful likelihood of causing the clinical situation. The APSS veterinarian stated that the tick collar was considered to have a doubtful likelihood of causing the clinical situation.