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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0134

2. Registrant Information.

Registrant Reference Number: 150104078

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.

31-JUL-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-JUL-15

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. 31368      PMRA Submission No.       EPA Registration No.

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

  • Active Ingredient(s)
    • (S)-METHOPRENE

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 July 15, 2015 the owner applied the product onto the two cats to treat for fleas.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

2

5. Sex

Male

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Lesion
    • Symptom - Rash
    • Symptom - Hair loss
    • Symptom - Pruritus

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 July 15, 2015 the cats developed symptoms. On July 31, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated signs are consistent with a dermal sensitivity reaction. The APSS assistant recommended discontinuing the product usage, monitoring for dermatological signs, taking the cats to the veterinarian (if skin gets infected), having the veterinarian call for information, calling back with questions, and consulting with a veterinarian (about another method of flea control since this one only kills the eggs).


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs expected to be mild and self-limiting.