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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0061

2. Registrant Information.

Registrant Reference Number: 150065467

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.

19-MAY-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-MAY-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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 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 May 15, 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

Shih Tzu Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.67

7. Weight (provide a range if necessary )

12.0

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change

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

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 May 15, 2015 the dog developed symptoms. The owner then bathed the dog (with face cloth and warm water on site). On May 16, 2015 the owner called an emergency veterinarian, who recommended giving the dog diphenhydramine (12 milligrams (mg)) and hydrocortisone cream (apply to affected area), which the owner did. On May 18, 2015 the owner bathed the dog with liquid dish washing detergent (LDWD). On May 19, 2015 the owner called the Animal Product Safety Service (APSS). The APSS veterinarian stated this product can cause a mild dermal irritation. The APSS veterinarian also stated some animals react to this with lethargy, hiding, or potentially hyperactivity and signs may last up to 24-72 hours. The owner stated the dog's pruritus ended while speaking with the APSS. The APSS technician stated that since the dog was returning to normal, can continue to monitor the dog at home, discontinue product usage, and continue recommendations from the veterinarian if desired. The APSS technician also stated that symptoms usually last for 3-4 days, but nothing permanent is expected and some hair loss may be seen from the area of application. The APSS technician also recommended calling 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

Signs were expected to be mild and self-limiting.