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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0123

2. Registrant Information.

Registrant Reference Number: 160021760

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.

15-FEB-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-FEB-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.

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 February 14, 2016 the owner applied the product onto dog to treat 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

Pomeranian Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

31.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Specify - Jittery
  • General
    • Symptom - Abnormal behaviour
    • Specify - Rolling
  • Skin
    • Symptom - Erythema
  • Nervous and Muscular Systems
    • Symptom - Restlessness

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 February 15, 2016 the dog became symptomatic.The owner bathed the dog (with human shampoo) and clipped the dog's hair (owner gave a hair cut because they thought the pet was hot). The owner then contacted the Animal Product Safety Service (APSS). The APSS technician stated a paresthesia reaction is possible with any topical product. The APSS technician recommended monitoring the dog at home, applying vitamin E and a cold compress (on the application site), taking the dog to the veterinarian (if skin breaks open), 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

On February 17, 2016 the owner called the APSS back. The owner stated the dog was still jittery and experiencing restlessness, but the erythema had ended on February 16, 2016. The owner stated the dog did not get a bath with dish washing detergent and the APSS veterinarian stated it would be unlikely to be beneficial at this point. The APSS veterinarian stated that if a paresthesia type reaction, may last as long as 5 days, but should be improving at this point. The owner stated the dog is a bit high strung, so applying the vitamin E oil or cool compress was not attempted. The APSS veterinarian recommended consulting with a veterinarian. The owner requested the phone number to consult the company regarding cost assistance. The APSS veterinarian provided the referral to the manufacturer (gave phone number for Zodiac Canada, as well as hours of operation and told the owner to listen for customer service option).