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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6472

2. Registrant Information.

Registrant Reference Number: 130109870

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.

07-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

07-AUG-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 13799-2

Product Name: Four Paws Magic Coat Flea And Tick Shampoo For Cats And Kittens

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .15 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .09 %
    • PYRETHRINS
      • Guarantee/concentration .045 %

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 August 7, 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

Medical Professional

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 )

9.0

7. Weight (provide a range if necessary )

14.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Recumbent
  • General
    • Symptom - Other
    • Specify - Torn Nails
    • Symptom - Death
  • Blood
    • Symptom - Bleeding

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 August 7, 2013, shortly after being bathed with the shampoo product, the owner noticed that the cat was recumbent and bloody. The owner took cat to vet; cat was dead on arrival. Veterinarian discovered blood was from 2 torn toenails and discovered a scratch on the cats head. Veterinarian believes its a sign of a seizure. Later that day the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that with overdoses, seizures and death would not be expected, and signs would not be expected to develop so quickly after the exposure. The APSS veterinarian recommended that a necropsy be performed to determine the cause of the cat's death.


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 and that hypertrophic cardiomyopathy was considered to have an unknown likelihood of causing the clinical situation. On August 7, 2013 an APSS technician contacted the owner's regular veterinarian to check on the status of the necropsy; the owner's regular veterinarian was not certain if a necropsy would be done. On August 9, 2013 the owner's regular veterinarian contacted the APSS to state that the owners did not wish to pursue a necropsy.