Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6640

2. Registrant Information.

Registrant Reference Number: 150107720

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.

07-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

01-AUG-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. 2724-504

Product Name: Zodiac Spot On Plus Flea And Tick Control For Cats 5 Pounds And Over

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 40 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 July 31, 2015 the owner applied the product onto the cat as treatment.

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 Longhair

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 )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Collapse

• 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?

Unknown

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 August 1, 2015 the cat developed a behavior change (wanted to go outside for the first time). On August 3, 2015 the cat developed vocalization (meowing insistently). On August 6, 2015 the owner bathed the cat (using Hartz infusions cat and kitten shampoo) and shortly after the cat collapsed, so the owner took the cat to the veterinarian, where cardiopulmonary resuscitation was performed and oxygen was given. The cat died shortly after. On August 7, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS veterinarian finally stated initial signs may have been due to paresthesia, but death is not expected. The APSS veterinarian recommended having the veterinarian call for information and having a necropsy done (not available as the pet was buried).

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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 substance was considered to have a doubtful likelihood of causing the clinical situation.