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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0221

2. Registrant Information.

Registrant Reference Number: 100115136

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-SEP-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

31-AUG-10

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 June 30, 2010, the owner applied the product onto three cats in the household. On August 30, 2010, the owner re-applied the product to one of those three cats.

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

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Skin
    • Symptom - Pruritus
    • Symptom - Hair loss

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 August 31, 2010 the cat became symptomatic. On September 2, 2010 the owner e-mailed to report the case. The veterinarian stated some animals are more sensitive to these products and may develop dermal hypersensitivity reactions characterized by rubbing or scratching at the application site, agitation, lethargy, hiding and gait abnormalities due to the tingling sensations they may feel. The assistant recommended the owner call the Animal Product Safety Service (APSS) or Central Life Sciences (CLS) with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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
  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Licking
  • Skin
    • Symptom - Hair loss

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement 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 July 1, 2010 the two cats became symptomatic. Both cats fully recovered on July 2, 2010. On September 2, 2010 the owner e-mailed to report the case. The veterinarian stated some animals are more sensitive to these products and may develop dermal hypersensitivity reactions characterized by rubbing or scratching at the application site, agitation, lethargy, hiding and gait abnormalities due to the tingling sensations they may feel.


To be determined by Registrant

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

Minor

19. Provide supplemental information here