Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-3440

2. Registrant Information.

Registrant Reference Number: 120047811

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.

16-APR-12

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

16-APR-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.       PMRA Submission No.       EPA Registration No. 2724-404

Product Name: Vet Kem Ovitrol Plus Flea Tick and Bot Spray

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .27 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .62 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .37 %
  • PYRETHRINS
    • Guarantee/concentration .2 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Other / Autre

Préciser le type: Relay

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

On April 9, 2012 the owner had applied the product to a pregnant dog. On April 15, 2012 the dog gave birth, and a puppy was exposed to the product by relay via an unknown route.

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

Dog / Chien

3. Breed

Catahoula Leopard Mix

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.002

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

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 - Death

12. How long did the symptoms last?

Persisted until death

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

Died

16. How was the animal exposed?

Other / Autre

specify Relay

17. Provide any additional details about the incident

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

On April 16, 2012 the owner observed that the puppy died. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the time of application to the bitch and the fact that it was only applied to the dorsum would not provide a significant exposure to a neonate. The APSS veterinarian also stated that the death was likely related to a post-whelping event. The APSS technician provided information to the owner, explaining that the product was not related to the puppy's death.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to the clinical situation. On April 17, 2012 an APSS technician called the owner to offer a necropsy. However, at this time a necropsy would not be available due to the amount of time that has passed since the puppy died. Label states in large bold letters: Consult a Veterinarian before using this product on debilitated, aged, pregnant, nursing, or animals on medication.