Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0980

2. Registrant Information.

Registrant Reference Number: 110103602

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.

11-AUG-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-AUG-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. 25739      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Siphotrol 1000 Double Action Premise Treatment

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On August 8, 2011 the owner sprayed the product throughout the house. Later that day, the owner applied a topical flea treatment to the cat.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

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 )

6.5

7. Weight (provide a range if necessary )

7.1

kg

8. Route(s) of exposure

Oral

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• Eye
  • Symptom - Other
  • Specify - Stare

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

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• Gastrointestinal System
  • Symptom - Mouth Irritation
  • Specify - Oral Ulcers

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On August 9, 2011 the owner noticed the cat was anorexic. Sometime between August 9 and August 11, 2011 the owner noticed the cat's behavior had changed, and that it was not listening to the owner. On August 10, 2011 the owner noticed the cat was staring. On August 11, 2011 the owner took the cat to the veterinarian, where the cat had an isolated event of muscle tremors and an oral ulcer was discovered. The tremors were an isolated event, and were no longer present when the regular veterinarian performed a physical examination on the cat. Per the veterinarian, at an unknown date and time the owner had used a syringe to give water to the cat. Shortly after examining the cat, the regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that if the product was ingested, there were risks for hypersalivation and nausea. The APSS veterinarian further stated that central nervous system (CNS) signs that are intermittent and of the duration given in this case would not be expected. The APSS veterinarian recommended that the regular veterinarian perform a diagnostic evaluation including labs and possibly other diagnostic procedures if the owner accepted, provide symptomatic care, 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 not considered to be related to causing the clinical situation.