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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2862

2. Registrant Information.

Registrant Reference Number: 130038530

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.

27-MAR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

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 unspecified date in the autumn of 2012 the owner applied an unknown amount of the product to the cat to prevent fleas; she stated that she did not apply the entire amount of the product at that time. On March 16, 2013 the owner applied 1.8 cubic centimeters (cc) of the product to the cat as a preventative. Cat is diabetic and has been receiving insulin for 6 years

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

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13.0

7. Weight (provide a range if necessary )

18.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Melena
  • General
    • Symptom - Hiding
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
    • Symptom - Adipsia
  • Respiratory System
    • Symptom - Laboured breathing
  • General
    • Symptom - Other
    • Specify - Not Meowing
  • Nervous and Muscular Systems
    • Symptom - Fasciculations
  • 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

At an unknown time after the owner initially applied the product to the cat in the autumn of 2012 the owner noticed that the cat had vomited several times. The owner applied the product to the cat again on March 16, 2013, and on March 18, 2013 the owner noticed that the cat had been hiding and was vomiting and experiencing melena; the owner then gave the cat some Karo syrup. On March 19, 2013 the owner noticed that the cat was anorexic, lethargic, and adipsic. On March 21, 2013 the owner observed that the cat was experiencing labored breathing. On an unspecified date the owner noticed that the cat was not meowing and was having fasciculations. On March 23, 2013 the owner observed that the cat died. On March 27, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product is a pyrethroid and that a taste reaction, gastrointestinal (GI) upset, and dermal hypersensitivity could be seen but the other signs would not be expected. The APSS veterinarian recommended that the owner call back with questions. A necropsy was not available.


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. Unknown if vet was consulted prior to application on medicated cat.