Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-3179

2. Registrant Information.

Registrant Reference Number: 090001727

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.

05-JAN-09

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

05-JAN-09

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. 2724-485-270

Product Name: Bio Spot Shampoo For Cats And Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .1 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 1.5 %
  • PYRETHRINS
    • Guarantee/concentration .15 %

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7. b) Type of formulation.

Liquid

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 January 3, 2009, the owner applied the product to her 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

Ragdoll Cat

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• 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 January 5, 2009, the cat began to seize. Shortly thereafter on January 5, the pet died. Also on January 5, 2009, the owner called the Animal Product Safety Service (APSS). The APSS veterinarian stated that the signs were more severe than would be expected with exposure to the product. The APSS veterinarian recommended a necropsy and hair testing. Hair testing results confirmed a methoprene exposure. The hair sample was negative for traces of etofenprox. Hair testing results found methoprene only. According to the necropsy results, mild heart enlargement, obesity and stress of the shampoo could have predisposed the patient to cardiac and unexpected death.

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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. Per necropsy report, there is evidence of left ventricular hypertrophy which may have predisposed this patient to cardiac arrhythmia and unexpected death after the stress of the flea treatment. There are no significant underlying histologic lesions to explain the sudden death of this cat. Acute pyrethrin toxicity would not be expected to have any histologic lesions. On the liver insecticide screen, no pyrethroids were detected.