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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6462

2. Registrant Information.

Registrant Reference Number: 130125184

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.


Prov / State: VERMONT

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. 2724-504

Product Name: Zodiac Spot On Plus Flea And Tick Control For Cats 5lbs and over

  • Active Ingredient(s)
      • Guarantee/concentration 3.6 %
      • Guarantee/concentration 40 %

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 September 5, 2013 the owner applied the product to the cat to treat for fleas.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

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

<=30 min / <=30 min

11. List all symptoms


  • General
    • Symptom - Hiding
  • Respiratory System
    • Symptom - Dyspnea
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

On September 5, 2013, immediately after the product was applied to the cat, the owner noticed that the cat was hiding. On the morning of September 6, 2013 the owner noticed that the cat had dyspnea, and the died in the car as the owner was taking the cat to the veterinarian. Later that morning the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that death would not be expected. The APSS veterinarian recommended a necropsy and faxed the necessary forms to the clinic.

To be determined by Registrant

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


19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 9, 2013 an APSS assistant called the owner's regular veterinarian to check on the status of the necropsy; the owner's regular veterinarian stated that the body had been shipped to the diagnostic lab earlier that morning. On September 19, 2013 an APSS technician recorded the interim necropsy results in the case. The heart revealed left ventricular hypertrophy and the bone marrow revealed diffuse chronic hamatopiesis. A cause of death was not yet determined, but left ventricular hypertrophy (hypertrophic cardiomyopathy) syndrome could be a possibility; the bone marrow was likely responding to anemia; the hair seen in the digestive tract could be secondary to over-grooming after application of the topical flea product. Samples were collected for histopathology, toxicology, and appropriate ancillary testing; results are pending. The necropsy was not able to specify the cause of death, However, chronic hemorrhages in the brain suggest previous injury likely stroke and could be clinically significant