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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0165

2. Registrant Information.

Registrant Reference Number: 160111254

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.

29-JUL-16

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

29-JUL-16

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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II 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 29, 2016 the owner noticed that the cat was particularly itchy in the morning and was concerned about fleas so he applied the product onto the cat.

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

Domestic Shorthair Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

Oral

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

System

  • General
    • Symptom - Vocalizing
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change

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 29, 2016 almost immediately after the product was applied the cat developed symptoms. The owner then contacted the Animal Product Safety Service (APSS). The APSS assistant stated the risk is for sensitivity to the feel of the product on the skin. The APSS assistant recommended monitoring the cat at home for GI signs, providing a taste treat (small amount of juice or tuna with some of the water it came in), bathing the cat (wash with liquid dish washing detergent (LDWD), rinse thoroughly, dry with a towel and keep pet warm), and calling back with questions (if signs are persistent or worsening). That afternoon the owner called the APSS back to confirm no serious signs were expected. The owner stated he had taken the cat to the veterinarian (for 4 hours to monitor for signs) and the cat was now home and he was concerned about the application site still being wet. The APSS veterinarian reviewed the case with the owner and assured him this would not be serious for the cat. The APSS veterinarian recommended if the owner felt the cat continued to be bothered by the product he could bathe the cat (LDWD) or just continue to monitor the cat at home.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs were expected to be mild and self-limiting.