Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6468

2. Registrant Information.

Registrant Reference Number: 130103555

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.

26-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

Unknown

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).

The owner bathed the cat with the shampoo product on July 20, 2013 and inappropriately bathed the cat with the same product again on either July 24 or 25, 2013 to treat for fleas.

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

Siamese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • 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 June 22, 2013 or June 23, 2013 the owner noticed that the cat was anorexic. On July 25, 2013 the owner noticed that the cat was vomiting and ataxic as well. On July 26, 2013 the owner observed that the cat had died. Later that evening the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that without more information the case could not be assessed fully at that time; with the cat's previous history of being outside and no veterinary visits, it would be hard to say what potential underlying issues the cat may have had at the time the shampoo product was used. The APSS veterinarian recommended that the owner take the cat's body to the veterinarian and have the veterinarian call the APSS for information regarding a necropsy.

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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 an unknown likelihood of causing the clinical situation. On July 29, 2013 an APSS technician called the owner to see if he wanted to pursue a necropsy for the cat. The owner stated that the body was no longer available, so a necropsy would not be possible.