Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5543

2. Registrant Information.

Registrant Reference Number: 100091024

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.

14-JUL-10

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

11-JUL-10

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. 2724-504-270

Product Name: Bio Spot Spot On Flea and Tick Control 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.

1.804

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 10, 2010 the owner applied the product onto the 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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

14

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hiding
  • Symptom - Vocalizing
  • Symptom - Hesitancy to move

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Death

• Renal System
  • Symptom - Other
  • Specify - kidney failure

12. How long did the symptoms last?

Persisted until death

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

Unknown

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 July 11, 2010 the cat was not as social and started hiding. On July 13, 2010 the cat started vocalizing and was hesitant to move, so the owner bathed him with baby shampoo three times. On July 14, 2010 the APSS veterinarian stated cats generally tolerate this product quite well, though some will object to sensation of any spot on product on the skin. The APSS veterinarian recommended taking the cat to the veterinarian for an assessment to rule out a serious illness and having the veterinarian call for information.

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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. On July 16, 2010 an APSS assistant called the owner to follow up the case. The owner stated the cat was not doing well and was headed into the veterinary clinic. On July 20, 2010 the owner returned the APSS's follow up and stated the cat had died on July 16, 2010 after arriving to the clinic. The attending veteriarian stated she thought the cat was in kidney failure and felt like the cat had an underlying problem before the product had been applied. The owner declined further consultation and the necropsy as the cat's body is not viable at this point.