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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0019

2. Registrant Information.

Registrant Reference Number: 110146093

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.

16-NOV-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-NOV-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 November 14, 2011 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.50

7. Weight (provide a range if necessary )

3.35

kg

8. Route(s) of exposure

Skin

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

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Discomfort
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Seizure
    • Symptom - Other
    • Specify - Sedate

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

Not recovered / Non 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 November 14, 2011, shortly after the product was applied, the owner noticed that the cat had pruritus and was experiencing discomfort. The owner bathed the cat later that evening to remove the product. On November 15, 2011 the owner noticed that the cat had additional symptoms. The owner took the cat to the veterinarian that morning. On November 16, 2011 the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS toxicologist stated that a dermal reaction could occur and that seizures were not expected. The APSS toxicologist also stated that an exposure to permethrin should be considered. During the consultation, the regular veterinarian stated that the cat was no longer pruritic, experiencing discomfort, having tremors, or having seizures. The APSS assistant asked that an APSS veterinarian contact the regular veterinarian to determine what cares were given.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS toxicologist stated that the flea and tick spot on product was not considered to be related to causing the clinical situation and that permethrin was considered to have a medium likelihood of causing the clinical situation. Shortly after the owner contacted the APSS on November 16, 2011, an APSS toxicologist contacted the regular veterinarian to update the case. The regular veterinarian stated that on November 15, 2011 the cat was given Diazepam, Propofol, and symptomatic care. The regular veterinarian also stated that on November 16, 2011 the cat had become sedate. The APSS toxicologist recommended permethrin hair testing. On November 18, 2011 an APSS technician called the regular veterinarian to discuss hair testing, and the regular veterinarian stated that the owners had rejected hair testing.