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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7150

2. Registrant Information.

Registrant Reference Number: 120171770

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.

13-DEC-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-DEC-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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot 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 December 8, 2012 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

Maltese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

12.0

kg

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

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

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Diarrhea
  • General
    • Symptom - Hiding
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Specify - Hind Limb Weakness
  • General
    • Symptom - Abnormal behaviour
    • Specify - Circling
  • Nervous and Muscular Systems
    • Symptom - Fasciculations

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?

No

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 the evening of December 8, 2012 the owner noticed that the dog was symptomatic. On December 9, 2012 the owner noticed that the dog was hiding, experiencing hind limb weakness and fasciculations, and circling. On December 10, 2012 the owner took the dog to the veterinarian, where a physical examination was performed and the dog was given medication to manage the diarrhea and an oral pain medication to control pain. Later that afternoon, the owner bathed the dog with liquid dish washing detergent (LDWD) and applied vitamin E to the dog; the owner continued to apply vitamin E oil. On December 12, 2012 the owner observed that the dog no longer had diarrhea, but remained symptomatic. On December 13, 2012 the owner took the dog back to the veterinarian. Later that afternoon, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal irritation or contact hypersensitivity could occur, as with any topical exposure, and that in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with topical permethrin. The APSS veterinarian also stated that if the product were ingested, gastrointestinal (GI) upset and/or a taste reaction could occur. The APSS assistant did not provide the owner with treatment recommendations because the owner did not wish to continue the consultation.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here