Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0040

2. Registrant Information.

Registrant Reference Number: 110074293

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-JUN-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-JUN-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)

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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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.5

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 14, 2011 the owner applied the product to his under aged kitten.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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 )

0.17

7. Weight (provide a range if necessary )

2.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

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 June 14, 2011 the owner noticed the cat was symptomatic. The vocalizing was an isolated event, but the other signs continued. Later that evening, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product was used off-label and that the product contains an insect growth regulator (IGR), which generally carries a wide margin of safety. The APSS veterinarian also stated that clinical signs other than dermal irritation or hypersensitivity were not expected. The APSS technician recommended that the owner bathe the cat with liquid dish washing detergent (LDWD), provide thermoregulation, put Karo or maple syrup on the cat's gums, take the cat to the veterinarian if the signs continued more than 30 to 60 minutes, and call back with questions.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a low likelihood of causing the clinical situation. On June 17, 2011 an APSS assistant called the owner to update the case. The owner stated that she bathed the cat with LDWD on June 14, 2011, shortly after speaking with the APSS. The owner also stated that the cat's signs had all ended and the cat had made a full recovery later that evening. Label clearly states to not use on cats under 12 weeks of age.