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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6017

2. Registrant Information.

Registrant Reference Number: 190092679

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.

30-MAY-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-MAY-19

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Over 14 kg (30 lbs)

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

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 May 26, 2019, the owner applied the product to 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

Old English Sheepdog Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.58

7. Weight (provide a range if necessary )

51.0

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

  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • Gastrointestinal System
    • Symptom - Retching
  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Pruritus
    • Specify - Application Site Pruritus
  • Gastrointestinal System
    • Symptom - Anorexia

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

A couple hours after the product was applied on May 26, 2019, the dog had an isolated event of restlessness. The next morning on May 27, 2019, the dog had an isolated event of retching and developed lethargy and application site pruritus. On May 30, 2019, the dog developed anorexia and the lethargy become moderate. Later that afternoon, the owner contacted the Animal Product Safety Service (APSS). The APSS assistant stated that the risk is for dermal sensitivity and paresthesia. The APSS assistant recommended the owner monitor at home, give the dog a bath (dish washing liquid (DWL) bath, wash and rinse twice), treat with vitamin E, consult with a veterinarian (for alternative flea treatment), take the dog to a veterinarian (if signs do not improve with at home care), and to call back with questions.


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.