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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0342

2. Registrant Information.

Registrant Reference Number: 110148879

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.

22-NOV-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-NOV-11

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea And Tick Control For Dogs Under 14 kg

  • 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 November 21, 2011 the owner applied the product to the dog to treat for fleas.

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

Canine Domestic Unspecified Mix

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 )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Symptom - Erythema

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 November 21, 2011 the owner noticed that the dog was symptomatic. Later that evening, the owner bathed the dog twice with puppy shampoo, but the baths weren't very effective at relieving the dog's signs. On November 22, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that some dogs may have skin sensitivity and develop an itching or tingling sensation at the application site, causing them to scratch and potentially causing secondary hair loss. The APSS veterinarian recommended that the owner bathe the dog with liquid dish washing detergent (LDWD) and warm water, apply vitamin E to the dog, and give 25 milligram (mg) capsules of Diphenhydramine to the dog.


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.