Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3862

2. Registrant Information.

Registrant Reference Number: 110073230

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.

12-JUN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

12-JUN-11

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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7. b) Type of formulation.

Dust

Application Information

8. Product was applied?

Yes

9. Application Rate.

.75

Units: oz (wts) / oz (pds)

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 June 12, 2011 the owner applied the product to the under label aged kitten.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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 )

0.13

7. Weight (provide a range if necessary )

1.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• General
  • Symptom - Lethargy
  • Symptom - Death

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 the evening of June 12, 2011 the owner noticed the kitten had symptoms. After noticing these signs, the owner bathed the kitten with a flea and tick shampoo and dipped the kitten in another product which contained permethrin. Later that evening, the owner induced emesis by giving milk and water. Shortly after, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the use of flea and tick powders as per label instructions is not expected to cause significant clinical signs, and that the concentration of active ingredients is typically quite low, so even ingestion of the agent via licking does not pose a significant threat of toxicity. The APSS veterinarian also stated that the signs described by the owner were not at all likely related to the use of the agent, and that even the off label use of the product in a kitten that is too young would not be expected to cause significant signs. The APSS assistant recommended that the owner bathe the kitten with liquid dish washing detergent (LDWD) and rinse thoroughly, take the kitten to the veterinarian, have the veterinarian call for information, and call back with questions.

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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 not considered to be related to causing the clinical situation. On June 14, 2011 an APSS assistant called the owner to update the case. The owner stated she bathed the kitten with LDWD as instructed on June 12, 2011 shortly after speaking with the APSS. The owner also stated the kitten died, but the owner was disconnected before a date or time of death could be given. An attempt to call the owner back after the call was disconnected was unsuccessful. Label states do not use on dogs or cats under 12 weeks of age.