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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0118

2. Registrant Information.

Registrant Reference Number: 120094957

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.

10-JUL-12

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

03-JUL-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)

PMRA Registration No. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control For Cats And Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE

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 June 29, 2012 the owner applied the product to the cat 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

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

12.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Erythema
    • Symptom - Lesion
    • Specify - Sore
  • General
    • Symptom - Vocalizing
    • Symptom - Hiding
  • Gastrointestinal System
    • Symptom - Anorexia

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

Not recovered / Non rétabli

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 July 3, 2012 the owner noticed that the cat was symptomatic. On July 6, 2012 the owner applied a neomycin polymyxin B and bacitracin ointment to the cat. On July 7, 2012 the cat was no longer anorexic, but the other symptoms persisted. On July 10, 2012 the owner applied a cold compress to the cat. A short time later, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal signs could be seen and that in response to the skin sensation caused by dermal application. The APSS assistant told the owner that the cat's reaction was more than what would be expected from the product and recommended that the owner take the cat to the veterinarian for further evaluation and 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

On July 12, 2012 an APSS assistant called the owner to update the case. The owner stated that she was not able to take the cat to the veterinarian and that the cat's condition was improving. The owner said that the cat was no longer hiding on July 10, 2012 and he was no longer vocalizing on the morning of July 12, 2012. Per the owner, the cat still had erythema and sores. The APSS assistant reiterated that the owner should take the dog to the veterinarian if possible.