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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2854

2. Registrant Information.

Registrant Reference Number: 130003182

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.

08-JAN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-813-270

Product Name: Bio Spot Defense Flea And Tick Spot On For Cats 5lbs + over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 an unknown date the owner applied the product to the cat to treat for fleas.

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 )

10.0

7. Weight (provide a range if necessary )

12.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Eye
    • Symptom - Pupil dilation
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
    • Symptom - Death
  • Eye
    • Symptom - Pupil dilation
    • Specify - mydryasis

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 an unknown date, soon after the product was applied, the owner noticed that the cat had mydriasis and displayed a change of behavior. On an unknown date after the signs developed, the owner took the cat to the veterinarian multiple times and force fed the cat. On an unknown date, the owner observed that the cat had died. On January 8, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the dose of etofenprox would not be expected to cause more than a dermal reaction, and possibly a paresthesia-type reaction. The APSS veterinarian also stated that the product spreading can cause an offensive sensation to some pets, resulting in odd behaviors or postures. The APSS assistant recommended that the owner have her veterinarian call to provide more information about the case.


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. Later on the morning of January 8, 2013 the owner's regular veterinarian contacted the APSS to update the case, but the call was disconnected before any new information could be obtained. Multiple attempts to update the case were unsuccessful.