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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6028

2. Registrant Information.

Registrant Reference Number: 180189332

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.

12-NOV-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-NOV-18

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 November 6, 2018, the owner applied this spray to the cat to treat a condition.

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

Ragdoll

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

6.6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle tremors
    • Symptom - Disorientation
  • Gastrointestinal System
    • Symptom - Fecal incontinence
  • Blood
    • Symptom - Leukocytosis
  • General
    • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Recvrd resid.effects/Rétabli séquelles

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

A couple hours after the product was applied on November 6, 2018, the cat developed ataxia, tremors, disorientation, and an isolated event of fecal incontinence. The owner then gave the cat a bath. Later in the evening, the owner took the cat to the emergency veterinarian who did a chemistry profile and complete blood count and noticed that the cat had developed leukocytosis (elevated white blood cell (WBC) count). The emergency veterinarian bathed the cat and advised that the cat stay at the clinic for three days but the owner declined. The cat was sent home with antibiotics (Cefaseptin 300 milligrams (mg)) and buprenorphine (0.5 mg). On November 7, 2018, the cat's tremors and disorientation resolved. On November 8, 2018, the cat developed lethargy. On November 9, 2018, the cat's ataxia resolved. On November 12, 2018, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that if animals are heavily saturated, there can be risks for central nervous system (CNS) depression and ataxia. Finally, the APSS veterinarian stated that CNS signs usually resolve within 24 hours and that changes in the WBC's, or for signs to persist, would not be expected. The APSS assistant recommended the owner refer to the manufacturer (for reimbursement) and to call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here