Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0086

2. Registrant Information.

Registrant Reference Number: 120052733

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.

25-APR-12

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

24-APR-12

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)

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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

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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 24, 2012 the owner applied the product to the dog to prevent 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

11.0

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

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• Nervous and Muscular Systems
  • Symptom - Agitation

• General
  • Symptom - Abnormal behaviour
  • Specify - Chasing Tail

• Skin
  • Symptom - Pruritus
  • Specify - Rubbing Application Site
  • 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 April 24, 2012 the owner noticed that the dog had pruritus shortly after the product had been applied. On April 25, 2012 the owner bathed the dog with an aloe and oatmeal shampoo for dogs. Later that morning, a person from the feed store where the owner had purchased the product contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that some animals are more sensitive to the ingredients in the product and can experience a dermal reaction. The APSS assistant recommended that the caller obtain additional information and that the owner bathe the dog with liquid dish washing detergent (LDWD) and apply a cold compress to the dog.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

A short time later on the morning of April 25, 2012 the owner contacted an APSS technician to update the case. The owner stated that on April 24, 2012, in addition to having pruritus, the dog also had erythema and was agitated, chasing his tail, and rubbing the application site. The APSS technician recommended that the owner apply vitamin E to the application area, monitor the dog for dermatological signs of redness and irritation, and call back with questions. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.