Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7167

2. Registrant Information.

Registrant Reference Number: 120152016

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.

31-OCT-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

25-OCT-12

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. 25582      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Siphotrol 2000 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 October 25, 2012 the owner sprayed the product around her home. Although she tried to keep the pets out of the treated area, a cat escaped and was accidentally exposed to the still-wet product.

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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy
  • Symptom - Polydipsia
  • Symptom - Abnormal behaviour
  • Specify - keeping her distance from other pets

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.

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?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On October 25, 2012, soon after the cat was exposed to the product, the owner noticed that she was vomiting. A short time later, the owner washed the cat's feet. The cat vomited 3 times over several hours that evening, and then the vomiting ended. At the time the vomiting ended, the owner noticed that the cat was lethargic, keeping her distance from other pets, and polydipsic, drinking more water than normal. Those signs ended on the evening of October 27, 2012, and the cat had fully recovered. On October 31, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that transient gastrointestinal (GI) upset is possible if the agent in ingested and that signs are typically self-limiting. The APSS assistant referred the owner to the product's manufacturer to discuss any non-medical concerns and recommended that the owner call back with questions.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Extra label use: cast was exposed to still-wet product.