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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0065

2. Registrant Information.

Registrant Reference Number: 150090834

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-JUL-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-JUN-15

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).

Starting on May 1, 2015 and again on June 1, 2015 the owner applied the product onto the dog for prevention.

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

Boston Terrier Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

45.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Ear
    • Symptom - Other
    • Specify - Ear Twitching
  • Renal System
    • Symptom - Other
    • Specify - Elevated Kidney Values
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Specify - Inability to Stand

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 June 23, 2015 the dog developed symptoms. On June 24, 2015 the owner took the dog to the veterinarian, where a physical examination, fluid therapy, complete blood count, and chemistry profile were done which revealed elevated kidney values. The dog was also bathed. On July 6, 2015 the owner contacted the Animal Product Safety Service (APSS) to report the case. The APSS veterinarian stated signs would be expected to be self-limiting. The APSS veterinarian also stated renal effects are not expected. The APSS technician recommended having the veterinarian call for information (to complete the medical report and report clinical findings) as the APSS veterinarian stated kidney failure is not related to the ingredients in the product.


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.