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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5841

2. Registrant Information.

Registrant Reference Number: 110133114

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.

17-OCT-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-SEP-11

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 September 23, 2011 the owner applied the product to his 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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

13.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Symptom - Vomiting
  • General
    • Symptom - Jaundice
  • Liver
    • Symptom - Hepatic failure

12. How long did the symptoms last?

Unknown / Inconnu

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

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 23, 2011 the owner noticed the cat was drooling and agitated shortly after the product was applied, and both of these were isolated events. On September 28, 2011 the owner noticed the cat was moderately inappetent and had severe vomiting. Between October 3 and October 7, 2011 the owner noticed the cat had icterus. Between October 11 and October 13, 2011 the owner noticed that the cat was severely inappetent and was no longer eating, and on October 12, 2011 the owner observed the cat was no longer vomiting. Between October 11 and October 15, 2011, the owner noticed the cat's icterus was worse. On October 14, 2011 the owner took the cat to the veterinarian, where 1 milliliter (mL) of Clavamox was prescribed to be given twice daily, the cat was given nutritional support because the owner had had to force feed the cat, and the cat was given fluids to treat its symptoms. Later that morning, the cat was observed to be in hepatic failure. On October 17, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS assistant recommended that the owner have his regular veterinarian call for information.


To be determined by Registrant

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

Major

19. Provide supplemental information here

A follow up was not performed, because no significant signs were expected. Therefore, the outcome of this case is unknown.