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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6644

2. Registrant Information.

Registrant Reference Number: 170124359

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.

21-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

20-JUL-17

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.       PMRA Submission No.       EPA Registration No. 2724-497

Product Name: Zodiac Spot On Flea And Tick Control For Dogs 7-15 lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.65

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 July 20, 2017 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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

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

  • Nervous and Muscular Systems
    • Symptom - Stiffness
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

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 applying the product, the owner bathed the dog. During the bath, the dog developed symptoms. A few minutes later, the owner was about to leave to take the dog to a veterinarian when the dog died. On July 21, 2017, the owner contacted the Animal Product Safety Service (APSS) whose veterinarian stated that permethrin is a pyrethroid and that dogs tolerate pyrethroids well. The APSS veterinarian stated that no life-threatening signs are expected and that pyrethroids can cause a pins and needles sensation or hyperesthesia, resulting in reluctance to move, mild tremors, paw shaking, ear twitching or facial fasciculations. Finally, the APSS veterinarian stated that methoprene is an insect growth regulator (IGR) with a wide margin of safety and that the oral lethal dose (LD50) in dogs is greater than (>) 5 grams per kilogram (g/kg).


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have an unknown likelihood of causing the clinical situation. A necropsy was not performed, as the dog had already been buried.