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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7158

2. Registrant Information.

Registrant Reference Number: 130003712

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.

09-JAN-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-JAN-13

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Over 14 kg

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

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 January 6, 2013 the owner applied the product to the dog to treat for fleas.

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

Australian Shepherd

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

30.0

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Anxiety
    • Symptom - Ataxia
  • Eye
    • Symptom - Blindness (temporary)
  • Nervous and Muscular Systems
    • Symptom - Trembling
    • Symptom - Muscle twitching
    • Specify - Facial Twitching

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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 January 8, 2013 the owner noticed that the dog was symptomatic. On the morning of January 9, 2013 the owner bathed the dog with baby shampoo. Later that afternoon, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the dog's signs were not consistent with an exposure to the product and that paresthesia can occur with an exposure to the product, but it is typically manifested differently. The APSS assistant recommended that the owner take the dog to the veterinarian, have the veterinarian call for information, call back with questions, and bathe the dog with liquid dish washing detergent (LDWD).


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 doubtful likelihood of causing the clinical situation and that ivermectin was considered to have an unknown likelihood of causing the clinical situation. On January 11, 2013 an APSS assistant called the owner to update the case. The owner stated that at an unknown time on January 9, 2013 she bathed the dog with LDWD and later that afternoon she gave the dog activated charcoal. The owner said that the dog had fully recovered by the evening of January 9, 2013.