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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0171

2. Registrant Information.

Registrant Reference Number: 160125584

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.

23-AUG-16

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

14-AUG-16

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 (30 lbs)

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

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 July 28, 2016 the owner applied the product to treat for a flea infestation that started on July 20, 2016. The owner did not see any improvement, so on August 11, 2016, the owner inappropriately applied the product onto the dog again.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Irish Wolfhound Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13.0

7. Weight (provide a range if necessary )

110.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Lesion
    • Specify - Ulceration

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

On August 14, 2016 the dog developed symptoms. A few hours later the owner applied triamcinolone (ViaDerm cream) onto the areas, but has not seen any improvement. On August 23, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated any dermally applied product can cause skin irritation and/or hypersensitivity reaction. The APSS veterinarian also stated topically applied pyrethrins/pyrethroids can cause tingling of the skin as well. The APSS veterinarian finally stated systemic signs are not expected as long as the product was used according to the label. The APSS assistant recommended taking the dog to the veterinarian (since no improvement, for an evaluation and treatment), having the veterinarian call for information, and calling back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. This was an off label use of product and an inappropriate duration between applications.