Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0086

2. Registrant Information.

Registrant Reference Number: 150059422

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.

07-MAY-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

06-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)

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PMRA Registration No. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea And Tick Control For Dogs Under 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.

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 6, 2015 the owner applied the product onto the dog as 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

Pomeranian Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

3.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Hyperactivity

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Pruritus
  • Symptom - Erythema

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

Not recovered / Non rétabli

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 6, 2015 the dog developed symptoms. On May 7, 2015 the owner gave the dog diphenhydramine (a little less than 1 milliliter (mL) of 6.2 milligram (mg) per 5 mL ending up with a dose of 0.03 mg/kg.) The owner then gave the dog another bath (using baking soda) and the dog developed erythema. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated sounds most like a paresthesia like reaction, suspect the reddened skin is secondary to the pruritus/scratching. The APSS technician recommended bathing the dog (using liquid dish washing detergent (LDWD), applying vitamin E (to the application site), applying a cold compress, calling back with questions, and taking the dog to the veterinarian (if redness continues after an hour).

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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

On May 9, 2015 an APSS technician called the owner to follow up on the case. The owner stated that the dog greatly improved after the bath with LDWD and she had not applied vitamin E or used a cold compress. The dog's hyperactivity, agitation, pruritus all ended on May 8, 2015 and the erythema became mild.