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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0789

2. Registrant Information.

Registrant Reference Number: 130128754

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.

13-SEP-13

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

01-MAY-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. 2724-504-270

Product Name: Adams Spot On Flea And Tick Control For Cats 5 Lbs And 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).

Beginning around May 1, 2013 and continuing monthly until August 6, 2013, the owner applied the product to the cat to prevent 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 )

13.0

7. Weight (provide a range if necessary )

21.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Weight loss
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Depression

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 May 1, 2013, shortly after the product was applied, the owner noticed that the cat's behavior had changed; he was less active and depressed, and overall it seemed that he had undergone a mood change. At that time, the owner also noticed that the cat was vomiting on and off. These signs continued for several months, and on September 13, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the ingredients in the product have a good margin of safety in cats. The APSS veterinarian also stated that chronic vomiting from multiple applications of the product was uncommon. The APSS technician recommended that the owner take the cat to the veterinarian if the signs continued.


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 causing the clinical situation. On January 13, 2013 the owner called the APSS to update the case. The owner stated that at an unknown time the cat had lost half of his body weight, and that at an unknown time in October 2013 she took the cat to her regular veterinarian, who suspected a brain tumor. Owner declined work up due to finances. The owner stated that the cat died on December 26, 2013. A necropsy was not available.