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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7049

2. Registrant Information.

Registrant Reference Number: 170068397

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.

27-APR-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

22-APR-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. 31367      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 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.

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 April 22, 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

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

9.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Symptom - Restlessness
  • Skin
    • Symptom - Pruritus
    • Symptom - Hyperesthesia
    • Specify - Dermal Hypersensitivity
    • Symptom - Other
    • Specify - Lump

12. How long did the symptoms last?

Unknown / Inconnu

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

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

On April 22, 2017 after applying the product to the dog, the dog developed agitation and restlessness. On April 27, 2017 the owner bathed the dog with diluted baby shampoo. Later that evening, the owner noticed that the dog developed pruritus, dermal hypersensitivity, and a lump about the size of a gum ball with a red dot in the middle, located where the product had been applied. The owner also noticed another lump at the base of the dog's skull, but was unable to identify if it had a red dot in the middle. The owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrins and pyrethroids can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus. The APSS veterinarian also stated that occasionally animals will develop sores or scabs, and alopecia secondary to scratching or biting the application site. The APSS veterinarian further stated that some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (take a few steps, stop, sit down and turn quickly toward their tail). The APSS veterinarian stated that signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. Finally, the APSS veterinarian stated that the initial signs are consistent with a reaction, but the lump that developed later is not consistent. The APSS assistant recommended that the owner bathe the dog (with liquid dish washing detergent, such as Dawn dish soap), apply a cool compress (recommended the owner use cool compress on area of irritation to aid with discomfort), vitamin E oil (recommended owner cut the tip of over the counter (OTC) vitamin E gel capsule and rub gel on area of irritation to aid in discomfort), 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 expected to be mild and self limiting.