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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-1021

2. Registrant Information.

Registrant Reference Number: 160185902

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.

15-DEC-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-DEC-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. 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 December 11, 2016 the owner applied the product onto the cat to treat condition.

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

Norwegian Forest

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

6.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Weight loss
    • Symptom - Other
    • Specify - Foreign Body Obstruction- Hairball
    • Symptom - Other
    • Specify - Dry Feces

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complčtement rétabli

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 December 11, 2016 the cat developed vomiting. Between December 12, 2016 and December 13, 2016 the cat developed anorexia and lethargy. On December 14, 2016 the owner took the cat to the veterinarian (where an anti-emetic, an appetite stimulant, and subcutaneous fluids were given, and blood work was done). On December 15, 2016 the owner took the cat back to the veterinarian where IV fluids were given and the veterinarian indicated they would implement force feeding if deemed necessary. Later that morning the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated s-methoprene has a wide margin of safety. The APSS veterinarian also stated drooling could be seen as a taste reaction. The APSS veterinarian additionally stated the severity and duration of these signs do not fit with an exposure to this product, there could possibly be something else going on with the cat. The APSS assistant recommended having the attending veterinarian call for information (for recommendations and to discuss the questions about s-methoprene).


To be determined by Registrant

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

Major

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 December 20, 2016 the attending veterinarian called the APSS to discuss the case. The attending veterinarian stated the cat's vomiting ended on December 13, 2016, but the cat developed weight loss (1.1 pounds). That same day, the cat was bathed. On December 14, 2016 the cat started vomiting again. On December 15, 2016 the attending veterinarian performed a barium series, where it was discovered the cat had a hairball which was causing a foreign body obstruction (FBO), and dry feces. On December 16, 2016 the attending veterinarian performed surgery to remove the FBO (hairball). On December 17, 2016 the attending veterinarian did an enema on the cat. On December 20, 2016 the cat fully recovered.