Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0010

2. Registrant Information.

Registrant Reference Number: 150063634

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.

15-MAY-15

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

12-MAY-15

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. 28599      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovitrol Dual Action Collar For Dogs And Puppies

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 May 11, 2015 the owner put the collar onto the dog for prevention.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.0

7. Weight (provide a range if necessary )

13.8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Loss of voice
  • Specify - Dysphonia
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change

• Cardiovascular System
  • Symptom - Arrhythmia

• General
  • Symptom - Other
  • Specify - dog stiffened

• Nervous and Muscular Systems
  • Symptom - Disorientation

• Renal System
  • Symptom - Inappropriate urination
  • Specify - urinated during the last event

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On May 12, 2015 the dog developed dysphonia (dog lost his bark or squeaky bark). On May 13, 2015 the dog experienced a behavior change (dog had an unknown episode that could have been a seizure as the dog stiffened, became disoriented, and urinated during this event that lasted 30 seconds), so the owner removed the collar. On May 14, 2015 the dog experienced a behavior change (during a walk the dog became restless, collapsed, and started drooling, which all lasted 30 seconds). On May 15, 2015 the owner took the dog to the veterinarian where the dog was diagnosed with an arrhythmia (attending veterinarian suspects atrial fibrillation). The attending veterinarian then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated systemic effects are not expected form dermal exposure to this agent. The APSS veterinarian finally stated intermittent signs and atrial fibrillation are not expected. The APSS veterinarian recommended supportive and symptomatic care, a diagnostic evaluation, bathing the dog, and calling 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 considered to have a doubtful likelihood of causing the clinical situation.