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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7035

2. Registrant Information.

Registrant Reference Number: 170081665

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.


5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.


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.


PMRA Registration No. 31367      PMRA Submission No.       EPA Registration No.

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

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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 17, 2017 the owner applied the product to the dog for prevention.

To be determined by Registrant

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


Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms


  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Itchy skin
    • Specify - Application Site Twitching
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Restlessness
    • Symptom - Other
    • Specify - Ear Twitching

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident


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

Shortly after applying the product on May 17, 2017 the dog developed agitation, application site twitching, and a behavior change. An hour later, on May 18, 2017 the dog developed vocalization and restlessness. Later that morning, the dog developed ear twitching. Then the owner contacted the Animal Product Safety Service (APSS). The APSS technician stated that some animals can be more sensitive to the ingredients and can experience a skin reaction. The APSS technician recommended a bath (with liquid dish washing detergent (LDWD), vitamin E (to the application site), monitor at home (for continued or worse signs), referral to the manufacturer, and to call back with questions.

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification


19. Provide supplemental information here

On May 18, 2017 the owner contacted the APSS because the dog was not improving. The owner bathed the dog, applied vitamin E, and gave 5 milligrams (mg) of cetirzine. The APSS veterinarian recommended the owner bathe again (or repeated warm bath, whichever brings the dog more relief), apply a cold compress, give diphenhydramine (6.25 mg by mouth (PO) 12 hours after the cetirzine), resume therapy (wait a few weeks to use a preventative product), consult with a veterinarian (for recommendations for flea and tick prevention), and to call back with questions.