Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6663

2. Registrant Information.

Registrant Reference Number: 150126603

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.

13-SEP-15

5. Location of incident.

Country: UNITED STATES

Prov / State: VERMONT

6. Date incident was first observed.

08-SEP-15

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-627

Product Name: Zodiac Flea And Tick Powder For Dogs Puppies Cats And Kittens

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 1 %
  • PYRETHRINS
    • Guarantee/concentration .1 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-401

Product Name: Zodiac Fleatrol Carpet And Upholstery Pump Spray

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .01 %
  • PERMETHRIN
    • Guarantee/concentration .28 %

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7. b) Type of formulation.

Liquid

Dust

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).

Between September 2, 2015 and September 4, 2015 the owner used the Zodiac flea and tick powder on the cat and the owner used the Zodiac carpet and upholstery spray and a flea and tick spray around the house; no witnessed exposures.

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 Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Weight loss
  • Symptom - Anorexia

• General
  • Symptom - Vocalizing
  • Symptom - Adipsia
  • Symptom - Weakness
  • 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

On September 8, 2015 the owner noticed the cat had weight loss (was down to about 1 pound by the time she died), anorexia, and adipsia. Later that evening the cat developed vocalization. On September 9, 2015 the cat developed weakness and died several hours later. On September 13, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the Zodiac flea and tick powder is safe for cats due to the low concentration of pyrethrins, dermal only exposure should cause no clinical signs. The APSS veterinarian also stated with the Zodiac flea and tick powder limited oral exposure may cause mild gastrointestinal (GI) upset. The APSS veterinarian stated the Zodiac carpet and upholstery spray and the flea and tick spray both have a wide margin of safety. The APSS veterinarian recommended a necropsy, which was not available (body had been disposed of).

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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 flea and tick powder was not considered to be related to causing the clinical situation. The APSS veterinarian stated that the Zodiac carpet and upholstery spray was not considered to be related to causing the clinical situation. The APSS veterinarian stated that the flea and tick spray was not considered to be related to causing the clinical situation.