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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-1022

2. Registrant Information.

Registrant Reference Number: 110063905

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-MAY-11

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

10-MAY-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. 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 May 1, 2011 the owner applied the product onto the two cats 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair, Domestic Shorthair

4. Number of animals affected

2

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Skin
    • Symptom - Lesion
    • Specify - Scab

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Fully Recovered / Complètement 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 May 10, 2011 the owner noticed both of the cats had a scab on the application site, so the owner applied Bacitracin ointment onto the scabs. On May 25, 2011 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated this product can cause a taste reaction with hypersalivation or gagging if groomed off the fur, and the ingredients in it may cause mild dermal irritation. The APSS veterinarian also stated some animals react to this with lethargy, hiding, or potentially hyperactivity and signs may last up to 24-72 hours. She further stated she would not expect signs from the product to be lasting this long. The APSS assistant relayed the APSS veterinarian's recommendations to take the cats to the veterinarian, have the veterinarian call for information, and discontinue the bacitracin ointment.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On May 30, 2011 an APSS assistant spoke with the owner upon follow-up who stated both cats fully recovered earlier that day.