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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0120

2. Registrant Information.

Registrant Reference Number: 150142422

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.

15-OCT-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

Unknown

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. 28382      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Dual Action Flea And Tick Spray For Cats And Kittens

  • 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 August 16, 2015 the owner applied the product onto the cat to treat 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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • General
    • Symptom - Hyperactivity
    • Symptom - Adipsia
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

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

Between August 15, 2015 and August 19, 2015 the cat developed lethargy and anorexia. On August 16, 2015 the cat developed agitation, hyperactivity, and adipsia. On August 19, 2015 the cat died. On October 15, 2015 a pet store employee contacted the Animal Product Safety Service (APSS) as the owner is blaming the product for the cat's death and requested a refund which was granted. The pet store employee stated that the owner buried the cat in the yard and was never seen by a veterinarian. The APSS veterinarian stated if animals are heavily saturated, there can be risks for central nervous system (CNS) depression and ataxia. The APSS veterinarian also stated if ingested, there can be signs of hypersalivation and nausea. The APSS veterinarian further stated some animals may have mild dermal hyperesthesia from the active ingredients, or agitation as the fleas are dying. The APSS veterinarian finally stated she would not expect risks for death from this product. The APSS veterinarian recommended obtaining additional information (signalment of the cat, signs seen, previous health history, etc). A necropsy was not available.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On November 9, 2015 the pet store employee called the APSS back as the owner wanted a refund from the manufacturer. The APSS assistant recommended referral to the manufacturer (to discuss reimbursement) and calling back with questions (if owner had direct questions).