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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6137

2. Registrant Information.

Registrant Reference Number: 140133345

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-OCT-14

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

01-OCT-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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Double Action Flea And Tick Shampoo For Dogs And Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • 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 September 29, 2014 the owner used the shampoo on the dog to treat for fleas.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Rottweiler Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.5

7. Weight (provide a range if necessary )

40.3

kg

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Muscle weakness
    • Specify - Hind Limb Weakness
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Weight loss

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 October 1, 2014 the dog developed tsymptoms. On October 6, 2014 the hind limb weakness worsened and the dog became anorexic (decrease in appetite 1 week post exposure) with weight loss (44.8 kg last visit 2 years ago, 40.3 kg now). On October 13, 2014 the anorexia worsened (dog now not eating at all). On October 20, 2014 owner took the dog to the veterinarian and the attending veterinarian called the Animal Product Safety Service (APSS). The APSS veterinarian recommended a diagnostic evaluation, supportive and symptomatic care.


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 no significant signs were expected.