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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5045

2. Registrant Information.

Registrant Reference Number: 1-26290893

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

Address: 100 STONE ROAD WEST, SUITE 111


Prov / State: ON

Country: CANADA

Postal Code: N1G 5L3

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


4. Date registrant was first informed of the incident.


5. Location of incident.



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.       PMRA Submission No.       EPA Registration No. 2724-497

Product Name: Zodiac Spot On Flea Control for Medium Dogs 31-60 lbs

  • Active Ingredient(s)
      • Guarantee/concentration 3 %
      • Guarantee/concentration 45 %

7. b) Type of formulation.


Application Information

8. Product was applied?


9. Application Rate.


Units: oz (fl) / oz (liquide)

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 25, 2011 the owner applied product to her dog.

To be determined by Registrant

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


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: Unknown / Inconnu

3. List all symptoms, using the selections below.


  • Skin
    • Symptom - Paresthesia
  • General
    • Symptom - Sweating
  • Respiratory System
    • Symptom - Difficulty Breathing
  • Nervous and Muscular Systems
    • Symptom - Slurred speech
  • Gastrointestinal System
    • Symptom - Other
    • Specify - unusual feeling in tongue
  • Cardiovascular System
    • Symptom - Chest pain
  • General
    • Symptom - Pain
    • Specify - arm pain
  • Respiratory System
    • Symptom - Bronchospasm
  • General
    • Symptom - Chemical taste in mouth
    • Specify - unpleasant taste

4. How long did the symptoms last?

Unknown / Inconnu

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


6. a) Was the person hospitalized?


6. b) For how long?

7. Exposure scenario


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


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


10. Route(s) of exposure.



11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 h

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.)

On May 25, 2011 the caller noted that one hour after applying product to her dog her hands were numb and tingling, and that she could taste the product. The caller is asthmatic and her rescue inhalers were no longer working therefore was transported to hospital emergency room via ambulance. She indicated being transported to hospital at approximately 9:00 am. While in ambulance claims being treated for chest pain with nitroglycerine and aspirin. While at hospital she indicated being given mulitple nebulizer treatements and diagnosed with bronchospasm due to sensitivity to the product.

To be determined by Registrant

14. Severity classification.


15. Provide supplemental information here.

Caller was instructed to avoid all contact with the animal. The caller was instructed best way to handle situation is to have dog decontaminated by a veterinarian so that she would have no further contact with the product. Caller was advised to remove contaminated clothing and rinse exposed skin with water for at least 20 minutes. Advised to seek medical care should symptoms return. Veterinarian determined symptoms inconsistent with product use.