Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6476

2. Registrant Information.

Registrant Reference Number: 130112961

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-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: RHODE ISLAND

6. Date incident was first observed.

19-JUL-13

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. 2724-813-270

Product Name: Bio Spot Defense Flea And Tick Spot On For Cats 5 LBs 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 17, 2013 the owner applied the product to the cat to treat for fleas.

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

Male

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

16.0

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

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

11. List all symptoms

System

• General
  • Symptom - Hiding

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy
  • Symptom - Weakness

• Respiratory System
  • Symptom - Laboured breathing

• 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.

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 July 19, 2013 the owner noticed that the cat was hiding, anorexic, and lethargic. The owner began monitoring the cat at home that day, and he thought he began to notice some improvement on July 20, 2013; however, on July 20, 2013 the owner did notice that the cat was weak. On the evening of July 21, 2013 the owner noticed that the cat's breathing was labored and the cat had several seizures. About an hour later that evening the owner observed that the cat had died; the owner had the cat cremated later that evening. On August 13, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian referred the owner to the product's manufacturer to discuss a formulation change. A necropsy was not available because the cat had already been cremated.

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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.