Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7048

2. Registrant Information.

Registrant Reference Number: 170051466

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.

01-APR-17

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

01-APR-17

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 April 1, 2017 the owner treated their house with this spray. The owner also applied topical and spray flea and tick products to the cat the same day. The cat ran into the room that was treated immediately after.

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 Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour

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?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

Almost as soon as the owner applied the spray to their home on April 1, 2017 the cat escaped into the room and ran across the treated floor. The owner is concerned that the cat may have licked his paws. The owner gave warm milk and water with a syringe. The cat began experiencing a behavior change (acting strange and standoffish). That same day, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that this product has a very low concentration of permethrin. The APSS veterinarian also stated that if the cat is sensitive to the product, the risk would be for tremors and seizures. For the topical product that was applied, the APSS veterinarian further stated that selamectin is a topical endectocide used in veterinary medicine and that in cats, the therapeutic topical dose is 6 milligrams per kilogram (mg/kg). The APSS veterinarian also stated that with overdoses, risks are for hypersalivation, central nervous system (CNS) depression, ataxia, and sedation and that mild dermal irritation may also occur. Finally the APSS veterinarian stated that there have been rare reports of seizures in both dogs and cats (both from the manufacturer and the APSS database). The APSS assistant recommended washing the cat's paws with a liquid dish washing detergent (LDWD) and to avoid stressing the cat out further by syringe feeding. The APSS assistant also recommended monitoring at home (for the next 72 hours for tremors or seizures) and to take to a veterinarian (if tremors/seizures are seen). Finally, the APSS assistant recommended the owner call back with any 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 topical product was considered to have a medium likelihood of causing the clinical situation. The cat should not have had access to the treated area until the spray had dried.