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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0300

2. Registrant Information.

Registrant Reference Number: 120131170

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.

18-SEP-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-SEP-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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray For Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 September 15, 2012 the owner sprayed the cat with the product to treat for fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

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?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Specify - Paw Shaking
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
    • Symptom - Vocalizing

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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 September 15, 2012 the cat had an isolated episode of drooling. A few minutes later, the owner bathed the cat with cat shampoo. A short time later that afternoon, the owner noticed that the cat was vomiting, shaking his paw, and exhibiting a behavior change by taking a few steps and lying down. That evening, the owner observed that the cat had an isolated episode of vocalizing. On the morning of September 17, 2012 the owner noticed that the cat was no longer symptomatic and had fully recovered. On September 18, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that dermal signs such as erythema, pruritus, and paresthesia, and that some animals exhibit abnormal behavior in response to the skin sensation caused by dermal application of the product. The APSS technician also stated that an oral ingestion could cause a taste reaction, such as hypersalivation, and gastrointestinal (GI) upset. The APSS technician recommended that the owner 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