Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0028

2. Registrant Information.

Registrant Reference Number: 150109953

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.

11-AUG-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

04-AUG-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)

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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

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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 August 4, 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

Bichon Frise

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

20.0

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

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

11. List all symptoms

System

• Skin
  • Symptom - Pruritus
  • Specify - Rubbing application site

• General
  • Symptom - Abnormal behaviour
  • Specify - Erratic Behavior

• Eye
  • Symptom - Pupil dilation

• Respiratory System
  • Symptom - Panting

• Nervous and Muscular Systems
  • Symptom - Trembling

• Ear
  • Symptom - Other
  • Specify - Ear twitching

• Gastrointestinal System
  • Symptom - Loss of appetite

• General
  • Symptom - Adipsia
  • Specify - Hypodipsia

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 August 4, 2015 the dog developed symptoms. Later that night, the owner bathed the dog (2 baths in Dawn). On August 5, 2015 the owner took the dog to the veterinarian, where a chemistry profile and fluid diuresis was done. The owner declined hospitalization, so brought the dog back to the clinic on August 6, 2015 for more fluids. On August 11, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dermal irritation or contact hypersensitivity may occur as with any topical exposure. The APSS veterinarian also stated in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS veterinarian finally stated if ingested, gastrointestinal (GI) upset and/or a taste reaction may occur. The APSS assistant recommended applying a cold compress and vitamin E, calling back with questions, taking the dog to the veterinarian (if area is scabbed over- may need re-evaluate to see if needs cleaned up or any other care), having the veterinarian call for information, and referring to the manufacturer (to discuss concerns about reimbursement for veterinary care).

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here