Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0070

2. Registrant Information.

Registrant Reference Number: 120060826

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.

10-MAY-12

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

05-MAY-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 May 5, 2012 the owner placed a collar on each of her two dogs.

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 Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

15.0

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• Skin
  • Symptom - Pruritus

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 5, 2012 the owner noticed that the dog was vomiting. Later that evening, the owner removed the collar from the dog. On May 7, 2012 the owner noticed that the dog's vomiting had worsened. By the evening of May 8, 2012 the owner observed that the dog had stopped vomiting. On May 9, 2012 the owner noticed that the dog had pruritus around the neck and the front legs. Later that day, the owner bathed the dog. On May 10, 2012 the owner's regular veterinary staff contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that propoxur is an organophosphate product and that if there was an oral exposure, signs could include hypersalivation and vomiting right after the exposure. The APSS veterinarian also stated that S-methoprene is an insect growth regulator of low toxicity and that an oral exposure could cause mild hypersalivation and nausea. The APSS veterinarian said that dermal-only exposures should not cause gastrointestinal (GI) signs, especially for such a long amount of time, and that other etiologies were suspected.

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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 substance was not considered to be related to causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting.

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

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

10.0

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Fully Recovered / Complètement rétabli

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 5, 2012 the owner noticed that the dog was vomiting. Later that evening, the owner removed the collar from the dog. By the evening of May 8, 2012 the owner observed that the dog had stopped vomiting. On May 9, 2012 the owner bathed the dog. On May 10, 2012 the owner's regular veterinary staff contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that propoxur is an organophosphate product and that if there was an oral exposure, signs could include hypersalivation and vomiting right after the exposure. The APSS veterinarian also stated that S-methoprene is an insect growth regulator of low toxicity and that an oral exposure could cause mild hypersalivation and nausea. The APSS veterinarian said that dermal-only exposures should not cause gastrointestinal (GI) signs, especially for such a long amount of time, and that other etiologies were suspected.

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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 substance was not considered to be related to causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting.