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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7004

2. Registrant Information.

Registrant Reference Number: 170134289

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-AUG-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

04-AUG-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. 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)
    • (S)-METHOPRENE
    • PERMETHRIN

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 August 3, 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

Nova Scotia Duck Tolling Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.5

7. Weight (provide a range if necessary )

55.0

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Fasciculations

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

In the early morning hours on August 4, 2017 the dog developed symptoms. Later in the evening, the owner bathed the dog with dog shampoo. On August 5, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS assistant stated that permethrin is a pyrethroid and that dogs tolerate pyrethroids well. The APSS assistant stated that no life threatening signs are expected. The APSS assistant also stated 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. The APSS assistant stated that methoprene is an insect growth regulator (IGR) with a wide margin of safety. The APSS assistant recommended the owner bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E (to the application area), monitor for dermatological signs (redness/irritation), and have the regular veterinarian call for information.


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.