Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6951

2. Registrant Information.

Registrant Reference Number: 180002984

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.

05-JAN-18

5. Location of incident.

Country: CANADA

Prov / State: PRINCE EDWARD ISLAND

6. Date incident was first observed.

05-JAN-18

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. 28382      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Dual Action Flea And Tick Spray For Cats And Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 January 5, 2018 the owner applied the product to the dog as prevention. The owner inappropriately bathed the dog with the cat product when the dog's fur was dry. The product then dried into a powder and was left on the dog.

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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

Eye

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Eye
  • Symptom - Swollen eye

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

Shortly after the product was applied, the dog became symptomatic. The owner then rinsed the dog and bathed with Dawn dish soap. Soon after the bath, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that significant clinical signs are not expected from the per-label use of this agent. The APSS veterinarian also stated that if the agent got in the dog's eye, irritation and secondary corneal damage are possible. The APSS assistant recommended the owner flush the dog's eyes (very gently, rinse eye with water for a couple minutes), monitor at home (for further swelling/redness), take the dog to a veterinarian (if eye does not improve), and call back with questions (if swelling/redness persists). While on hold, the owner started rinsing the dog's eye with water and the eye appeared to be less swollen.

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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 were expected to be mild and self-limiting. This product was not was not labeled for use on dogs, it was not used according to the label instructions.