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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0038

2. Registrant Information.

Registrant Reference Number: 150127177

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.

14-SEP-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-SEP-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 September 14, 2015 the owner 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

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

15.0

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 - Drooling
  • General
    • Symptom - Hiding
  • Eye
    • Symptom - Squinting

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 September 14, 2015 the cat developed symptoms, so the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the risk is for a taste reaction, vomiting, and diarrhea. The APSS assistant recommended monitoring the cat at home for gastrointestinal (GI) signs (monitor for vomiting and diarrhea over the next 12-24 hours and call back if more than mild), providing a taste treat (give tuna juice, wet food, or dry food), and monitoring for dermatological signs (monitor for redness, irritation, or itching if seen, bathe with liquid dish washing detergent (LDWD)). The APSS assistant also recommended giving nothing by mouth (if vomits, nothing by mouth (NPO) 30 minutes), bathing the cat (with LDWD if dermal irritation is seen or if still squinting in 1 hour), calling back with questions, and calling the veterinarian (follow up with regular veterinarian for another product to kill adult fleas and to treat the 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.