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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7185

2. Registrant Information.

Registrant Reference Number: 130041341

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-APR-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

28-MAR-13

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 March 28, 2013 the owner applied the product to the cat to treat for fleas.

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

Ragdoll

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 )

11.2

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Shaking
    • Specify - Paw Shaking
    • Symptom - Trembling
  • Ear
    • Symptom - Other
    • Specify - Ear Twitching
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
    • Symptom - Adipsia
  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

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

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 / 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 March 28, 2013 the owner noticed that the cat was symptomatic. On the morning of March 29, 2013 the owner noticed that the cat had developed more signs; the owner noticed that the cat's behavior had changed and he was sticking his paws in his water instead of drinking, the cat was adipsic, and the cat was anorexic. That morning, the owner bathed the cat with liquid dish washing detergent (LDWD). The owner repeated the bath later that morning and gave the cat some water with a syringe since he refused to drink. That afternoon, the owner took the cat to the veterinarian, where fluid therapy was given; the owner did not provide additional details about the cat's treatment. On March 30, 2013 the owner observed that the cat had fully recovered. On April 2, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that methoprene is an insect growth regulator with a wide margin of safety and that although significant systemic effects would not be expected, a dermal paresthesia-type reaction could be seen, although that type of reaction is less common in spot on products that do not contain an insecticide. The APSS veterinarian referred the owner to the product's manufacturer.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

A follow up was not performed, because no significant signs were expected.