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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0134

2. Registrant Information.

Registrant Reference Number: 120135682

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.

27-SEP-12

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

23-SEP-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. 25582      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Siphotrol 2000 Double Action Premise Treatment

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

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: Res. - In Home / Rés. - à l'int. maison

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

On September 23, 2012 the owner sprayed the product in the house to treat for fleas. She kept the 2 dogs outside until later that evening.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

4.65

kg

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite

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?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On September 23, 2012 the owner noticed that the dog was symptomatic. On September 27, 2012 the owner took the dog to the veterinarian. Later that day, the owner's veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that (GI) signs would not be expected to last so long. The APSS veterinarian also stated that other possibilities for the dog's symptoms should be ruled out. The APSS veterinarian recommended that the owner's veterinarian perform a diagnostic evaluation, run a chemistry profile, obtain a complete blood count (CBC), provide fluid therapy, protect the GI tract, manage vomiting, provide symptomatic care, and call back with questions.


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 considered to have a doubtful likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

13.8

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Diarrhea

12. How long did the symptoms last?

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

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?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On September 24, 2012 the owner noticed that the dog was having diarrhea. The dog had fully recovered later that evening. On December 14, 2012 the owner contacted the APSS to obtain help. The APSS veterinarian stated that diarrhea is a very non-specific sign and could be due to a number of other reasons, such as food indiscretion, viral diarrhea, etc.


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 considered to have a low likelihood of causing the clinical situation. A follow up was not performed, because no significant signs were expected.