Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1402

2. Registrant Information.

Registrant Reference Number: 120173131

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-DEC-12

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

15-DEC-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)

---

PMRA Registration No. 21206      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovitrol Plus for Dogs and Cats

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

---

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: 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 December 15, 2012 the owner applied the product to the under label aged puppy 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

Dog / Chien

3. Breed

Labrador Retriever Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.12

7. Weight (provide a range if necessary )

1.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Anorexia

• General
  • Symptom - Weakness

• Gastrointestinal System
  • Symptom - Weight loss

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

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 December 15, 2012, shortly after the product had been applied to the puppy, the owner noticed that the puppy was vomiting; later that afternoon, the owner noticed that the puppy was anorexic as well. On December 16, 2012 the owner noticed that the puppy's vomiting was worse and that the puppy was weak and had lost weight. The owner immediately bathed the puppy with a pet shampoo. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the scent of the agent could have nauseated the puppy. The APSS veterinarian said that the concern with persistent signs would be dehydration and hypoglycemia. The APSS veterinarian recommended that the owner provide thermoregulation to the puppy, give the puppy honey and nutritional support of small volumes of puppy chow broth, take the puppy to the veterinarian, have the veterinarian call for information, and call back with questions.

---

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 considered to have a doubtful likelihood of causing the clinical situation. On December 18, 2012 an APSS assistant called the owner to update the case. The owner stated that she had been force feeding the puppy puppy chow broth and that on the morning of December 17, 2012 the puppy was vomiting and had a seizure. The owner stated that a short time later that morning, the puppy died. A necropsy was not available. Label clearly states: Do NOT use on nursing animals or on dogs or cats under 12 weeks of age.