Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0176

2. Registrant Information.

Registrant Reference Number: 160079843

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.

03-JUN-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-JUN-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)

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PMRA Registration No. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Over 14 kg

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

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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 June 3, 2016 the owner applied an inappropriate dose of 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?

No

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 )

2.0

7. Weight (provide a range if necessary )

11.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• 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.

No

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 3, 2016 the dog became symptomatic. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated permethrins and pyrethroids can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus and occasionally animals will develop sores or scabs, and alopecia secondary to scratching or biting the application site. The APSS veterinarian also stated some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (ex. take a few steps, stop, sit down and turn quickly toward their tail). The APSS veterinarian further stated signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. The APSS veterinarian finally stated oral exposures can lead to hypersalivation, vomiting, and diarrhea. The APSS assistant recommended monitoring the dog for agitation (monitor for 24 hours for panting, pacing, restless, jumpy), bathing the dog (bathe with liquid dish washing detergent (LDWD), applying vitamin E (to the application site after the bath), monitoring for dermatological signs, and calling back with questions.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs expected to be mild and self limiting. Off label use - wrong dose for dog's size.