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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0062

2. Registrant Information.

Registrant Reference Number: 120075892

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.

06-JUN-12

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

02-JUN-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 June 2, 2012 the owner applied the product to the dog to prevent 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

Pug Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

25.0

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Hyperactivity
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
  • Skin
    • Symptom - Erythema
  • General
    • Symptom - Hyperthermia
  • Skin
    • Symptom - Lesion
    • Specify - Abscess

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

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 June 2, 2012 the owner noticed that the dog was hyperactive. On June 3, 2012 the owner noticed that the dog was lethargic, having tremors, had erythema, and was hyperthermic. On June 4, 2012 the owner observed that the dog had an abscess. On June 5, 2012 the owner noticed that the dog was more lethargic and the dog's abscess had burst and gone away. That same day, the owner's daughter bathed the dog with a shampoo purchased from a pet store. On June 6, 2012 the owner took the dog to the veterinarian, where the dog was given an injection of Celestone and some treatments to be given at home. Later that day, the owner provided supportive care by giving 1/2 of a 250 milligram (mg) tablet of Clavaseptin and a dermal treatment using Mometamax. That day, the owner observed that the dog was no longer hyperactive, having tremors, or hyperthermic. Later that day, 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 some animals may also exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with topical permethrin. The APSS veterinarian recommended that the owner call 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 June 11, 2012 an APSS assistant called the owner to update the case. The owner stated that he continued to give the dog the treatments of Clavaseptin and Mometamax, as well as a daily bath, and by June 10, 2012 the dog was no longer lethargic. The owner also stated that although the dog's erythema had gotten better, it was still present, and she planned to continue giving the medications and baths.