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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7205

2. Registrant Information.

Registrant Reference Number: 130074201

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.

04-JUN-13

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

Unknown

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: mg/L

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 May 22, 2013 the owner applied the product to the geriatric dog to treat for fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

15.0

7. Weight (provide a range if necessary )

25.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
  • Skin
    • Symptom - Dermatitis
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - unable to lift his neck

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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

Between May 24 and May 25, 2013 the owner noticed that the dog was experiencing a behavior change, unable to lift his neck. At that time, the owner also noticed that the dog had dermatitis that appeared as clusters of small, hard bumps on the skin that seemed powdery. On May 26, 2013 the owner provided symptomatic care by applying an unknown prescription ointment and an unknown hand lotion to the dog's skin. Between June 2 and June 3, 3013 the owner observed that the dog's abnormal behavior had ended and he could lift his neck again. On the morning of June 4, 2013 the owner noticed that the dog's dermatitis was milder. Later that day the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that some individuals may experience local hypersensitivity in response to the application of a dermal product and that this situation was difficult to assess due to the owner's home treatments. The APSS technician recommended that the owner take the dog to the veterinarian if his signs continued and to call back if the pet developed signs from future applications of the product.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Unknown if vet consulted per label instructions before use on geriatric dog.