Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4401

2. Registrant Information.

Registrant Reference Number: 130041668

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.

02-APR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

02-APR-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. 2724-485-270

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 April 2, 2013 the owner bathed the cat with the shampoo product to treat for fleas.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• 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 April 2, 2013, shortly after bathing the cat with the product, the owner observed that the cat died suddenly. The owner immediately contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product does not have any residual effect, so toxicity and acute death would not be expected. The APSS veterinarian also stated that since the cat had had fleas for a few weeks, it would be possible that flea anemia, or underlying cardiac disease, and the stress of the bath led to heart failure. The APSS veterinarian recommended that the owner have a necropsy, have her veterinarian call for information if she decided to pursue a necropsy, 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 the clinical situation. On April 3, 2013 an APSS technician called the owner to discuss a necropsy; the owner declined to pursue a necropsy.