Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0271

2. Registrant Information.

Registrant Reference Number: 120142551

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.

11-OCT-12

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

11-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. 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 October 11, 2012 the owner placed the dual action collar on the puppy to treat for fleas but left too much excess collar material.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Irish Setter Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.37

7. Weight (provide a range if necessary )

28.0

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

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Retching
  • Symptom - Drooling

• Respiratory System
  • Symptom - Other
  • Specify - Increased Respiratory Effort
  • Symptom - Abnormal lung sounds
  • Specify - Upper Respiratory Sounds
  • Symptom - Coughing

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 October 11, 2012, shortly after placing the dual action collar on the puppy the owner noticed that the puppy was symptomatic. At some point that day, the owner removed the collar from the puppy. Later that day the owner took the puppy the the veterinarian. While at the clinic, the puppy was observed to have increased respiratory effort, upper respiratory sounds, and a cough. The owner's regular veterinarian bathed the puppy, gave Charcodote activated charcoal, and provided fluid therapy. A few minutes later that day, the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that propoxur is a carbamate insecticide that dogs's tolerate fairly well and that it is rare for dogs to develop clinical signs after exposure to the product. The APSS veterinarian also stated that if the puppy licked the collar, vomiting and drooling could be seen. The APSS veterinarian recommended that the owner's regular veterinarian run an atropine dose test by aminiistering 0.02 milligrams per kilogram (mg/kg) intravenously and monitoring over 10 minutes; if the heart rate became elevated, the exposure was not to a carbamate or an organophoshate. The APSS veterinarian also recommended that the owner's regular veterinarian provide symptomatic and supportive care and call 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 low likelihood of causing the clinical situation. Multiple attempts to update the case were unsuccessful; therefore, the outcome is unknown. Suspected exposure to unsafe collar.