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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6909

2. Registrant Information.

Registrant Reference Number: 170217367

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-DEC-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-DEC-17

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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Double Action Flea And Tick Shampoo For Dogs And Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • 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 December 6, 2017 the owner bathed the cat with the product as prevention.

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 Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.5

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Disorientation
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
    • Symptom - Vocalizing
    • Symptom - Adipsia
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Absent Bowl Movements

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 December 8, 2017 the cat developed symptoms. On December 11, 2017 the owner called their regular veterinarian, who stated the cat was experiencing pyrethrin toxicity. On December 12, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that these signs are not expected. The APSS assistant recommended the owner take the cat to a veterinarian, have the veterinarian call for information, referral to manufacturer (to discuss possible reimbursement), and to 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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On December 14, 2017 an APSS assistant called to follow up on the case. The owner stated the cat's signs have continued and have not gotten any better. The owner stated that they could not afford to take the cat to a veterinarian and the manufacturer was unable to send reimbursement until the cat was looked at by a veterinarian and confirmed that the signs were due to the product.