Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0344

2. Registrant Information.

Registrant Reference Number: 110152136

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.

30-NOV-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

22-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)

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PMRA Registration No. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray For Dogs and Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.5

Other Units: bottle

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 22, 2011 the owner sprayed the cat with half of the bottle to treat for fleas.

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

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

14.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• General
  • Symptom - Weakness

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• Skin
  • Symptom - Dry skin

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?

2

Day(s) / Jour(s)

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 November 22, 2011 the owner noticed that the cat was symptomatic. On November 23, 2011 the owner took the cat to the veterinarian, where unknown symptomatic cares were given. On November 25, 2011 the cat was given Imidacloprid and sent home with vials for the next 3 months. At that time, the owner also noticed that the cat's skin was dry. The owner observed that the dry skin had ended on the morning of November 30, 2011. Later that morning, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the owner likely used far more of the product than was recommended on the label, so it was possible that enough of the alcohol carrier was absorbed across the skin to cause intoxication in the cat. The APSS assistant referred the owner to the manufacturer to discuss product concerns and reimbursement.

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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

Cat was treated with too much of the product ( half of bottle) label directions state: The application of 8.5 mL of Zodiac Flea Tick Spray for Dogs and Cats per kilogram of body weight (i.e. 6 squeezes of the trigger sprayer per kilogram) will provide effective flea control. Given the residual control afforded by Zodiac Flea Tick Spray for Dogs and Cats, the application of this product once every 2 months should be adequate.