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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6020

2. Registrant Information.

Registrant Reference Number: 190114460

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.

02-JUL-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-JUL-19

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 2, 2019, the owner applied the product to the cat to treat a condition. It is known if veterinarian was contacted before use on geriatric cat with a history of urinary issues.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Himalayan

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14.0

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

  • Gastrointestinal System
    • Symptom - Salivating excessively
  • General
    • Symptom - Hiding
    • 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

After the product was applied on July 2, 2019, the owner saw the cat turn her head towards her back. The owner was concerned that the cat may have licked some of the product. After applying the product, the cat developed hypersalivation. The cat was also hiding and displayed a behavior change (the owner stated that the cat was acting scared and concerned that "something was on her".) The owner then contacted the Animal Product Safety Service (APSS). The APSS assistant stated that s-methoprene is an insect growth regulator (IGR). The APSS assistant also stated that if ingested there could be hypersalivation and nausea. The APSS technician recommended the owner monitor at home, monitor for gastrointestinal (GI) signs, manage vomiting (if pet vomits, remove food and water for an hour. Slowly reintroduce water with small sips. If no vomiting occurs at this point, can go about normal routine with food and water intake.), monitor for signs (taste reaction), give a taste treat (canned food or some milk), wipe off coat/skin, and to call back with questions.


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.