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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0252

2. Registrant Information.

Registrant Reference Number: 100118353

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.

09-SEP-10

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

06-SEP-10

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

PMRA Registration No. 22916      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Mousse for Cats and Dogs

  • 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 September 6, 2010 the owner applied the Zodiac spot on onto the cat. On September 7, 2010 the owner applied the Zodiac mousse onto the cat.

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 Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

5.18

kg

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

  • Gastrointestinal System
    • Symptom - Other
    • Specify - Tenesmus
  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Symptom - Ataxia
  • Eye
    • Symptom - Other
    • Specify - Anisocoria
  • Blood
    • Symptom - Hyperbilirubinemia
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Hyperthyroidism

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non 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 6, 2010 the cat became symptomatic. On September 7, 2010 the cat became recumbent, ataxic, and developed anisocoria. On September 8, 2010 the owner took the cat to the veterinarian where they bathed the cat, provided fluid therapy, activated charcoal, monitored the cat's blood pressure and heart rate, and performed a chemistry profile. On September 9, 2010 the cat again became recumbent, and was diagnosed with an elevated (alanine aminotransferase) ALT and albumin, so the attending veterinarian contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated no significant signs expected from use of this product. The APSS veterinarian also stated heavy application can cause some lethargy and grooming/oral exposure can cause taste reaction (drooling, retching) or paw shaking and ear flicking. The APSS veterinarian recommended a diagnostic evaluation, supportive and symptomatic care, and calling 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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 21, 2010 an APSS technician called the attending veterinary clinic to follow up the case. The attending veterinarian stated the owner chose not to continue treatment at the veterinary facility and signed the pet out against medical advice (AMA) and was to follow up with a veterinary neurologist. The attending veterinarian also stated after digging deeper into the cat's history, the cat had been having some central nervous system (CNS) signs prior to the application of the Zodiac product and the cat's signs are likely related to a possible central lesion. This product was not used according to label directions: consult a veterinarian before using on aged animals.