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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0265

2. Registrant Information.

Registrant Reference Number: 100128004

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-OCT-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-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 September 30, 2010 the owner applied the product onto the dog.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

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

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Symptom - Ataxia
  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Symptom - Abnormal gait

12. How long did the symptoms last?

Unknown / Inconnu

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

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 1, 2010 the dog developed symptoms, so the owner bathed the dog with shampoo. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated ataxia and falling over are not expected. The APSS assistant relayed the APSS veterinarian's recommendations to take the dog to the veterinarian, have the veterinarian call for information, call back with questions, and call the manufacturer to discuss efficacy questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On October 5, 2010 an APSS assistant called the owner to follow up the case. The owner stated that she had taken the dog to the vet, but didn't stay and he didn't receive treatment. The owner instead, monitored the dog at home on October 1, 2010. The APSS assistant relayed the APSS veterinarian's recommendations to bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E, call back with questions. On October 7, 2010 an APSS assistant called the owner to follow up the case. The owner stated the dog's skin is showing improvement, but still seems to have pruritus. The APSS assistant relayed the APSS veterinarian's recommendations to take the dog into the veterinarian if he did not show signs of improvement, rather than waiting until the weekend.