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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6036

2. Registrant Information.

Registrant Reference Number: 140146279

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.

17-NOV-14

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

09-NOV-14

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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 4, 2014 and again on November 6, 2014 the owner inappropriately applied the product onto the cat.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

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 )

14.0

7. Weight (provide a range if necessary )

8.0

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

  • Blood
    • Symptom - Anemia
  • Gastrointestinal System
    • Symptom - Bloody vomit
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

On November 9, 2014 the cat presented to the veterinary clinic with anemia, with a hematocrit of 25 percent, and a severe flea infestation, after the veterinarian removed at least 200 fleas with a flea comb, and then kept the cat overnight so the owner could treat the home for fleas. On November 10, 2014 the veterinary clinic administered a flea tablet to the cat and used the flea comb again (removed another 200 fleas). That afternoon the cat then had a seizure, bloody vomitus, and died as she was being taken out of the cage. On November 17, 2014 the attending veterinarian called the Animal Product Safety Service (APSS) to complain about how small the writing on the box was, which is why the elderly owner inappropriately dosed the cat. The attending veterinarian stated the cat was cremated. The APSS veterinarian stated the Zodiac spot on contains s-methoprene which is an insect growth regulator (IGR). The APSS veterinarian also stated if ingested there could be hypersalivation and nausea. The APSS veterinarian stated the flea tablet contains spinosad which is an anti-parasitic agent in the chemical class of tetracyclic macrolides. The APSS veterinarian further stated it is used in dogs at doses of 30-60 mg/kg for fleas and Plumb does not list a therapeutic dose for cats, but it is marketed for cats. The APSS veterinarian finally stated usually adverse reactions that can occur are vomiting, diarrhea, and mild lethargy; serious risks, seizures, and death are not expected. 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 Zodiac topical was not considered to be related to causing the clinical situation.