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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6018

2. Registrant Information.

Registrant Reference Number: 190104447

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


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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control For Cats And Kittens

  • 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 16, 2019, the owner applied this product to the cat as 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

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms


  • General
    • Symptom - Licking
    • Symptom - Other
    • Specify - Lump
  • Skin
    • Symptom - Lesion
    • Specify - Wound

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

About 30 minutes after the product was applied on May 16, 2019, the cat started licking the area where the product was applied. On May 19, 2019, the cat developed a lump, followed by a wound. The owner parted the cat's fur and noticed that the lump looked like a pimple. The owner stated that it opened up soon after and clear liquid came out. On May 20, 2019, the owner applied hydrogen peroxide (H2O2) and polymyxin B bacitracin ointment. On June 17, 2019, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that methoprene is an insect growth regulator and that oral exposures may cause a taste reaction (vomiting, salivation) and possibly a dermal hypersensitivity (erythema, itching, rubbing, reaction (especially in cats). The APSS veterinarian also stated that clinical signs are expected to be mild and self-limiting. The APSS assistant recommended that the owner monitor at home, continue treatment (but not the H2O2), take the cat to a veterinarian (if the wound gets worse), 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

Signs were expected to be mild and self-limiting.