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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-1019

2. Registrant Information.

Registrant Reference Number: 100141586

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.

01-NOV-10

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

28-OCT-10

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control For Dogs Under 14 kg

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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 28, 2010 the owner applied the product onto both dogs.

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

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Shaking

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

No

14. a) Was the animal hospitalized?

No

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 October 28, 2010 the dog began to shake, fully recovering later that day. On November 1, 2010 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated local dermal irritation, tingling feeling, mild shaking and nervousness can be seen in some sensitive dogs. No treatment was necessary as the dog had fully recovered before the APSS call.


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 medium 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 )

1.5

7. Weight (provide a range if necessary )

7

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Shaking
  • Skin
    • Symptom - Pruritus

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non 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 October 28, 2010 the dog began to shake. On October 29, 2010 the dog developed pruritus. On October 30, 2010 the owner took the dog to the veterinarian, where they bathed the dog. On November 1, 2010 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended to bathe the dog again with liquid dish washing detergent (LDWD), giving diphenhydramine, taking the dog back to the veterinarian if signs continue, and calling back with questions.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

On November 3, 2010 an APSS assistant called the owner to follow up the case. The owner stated that the dog's shaking had ended on on November 2, but the pruritus continued. The owner also stated she had bathe the dog with LDWD, but had not given the dog diphenhydramine or taken him back to the veterinarian.