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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7276

2. Registrant Information.

Registrant Reference Number: 130131392

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.

18-SEP-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-SEP-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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control For Cats And Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 September 17, 2013 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 )

15.0

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Depression
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Skin
    • Symptom - Pallor
  • Respiratory System
    • Symptom - Tachypnea
  • General
    • Symptom - Hypothermia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Not recovered / Non rétabli

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 September 18, 2013 the owner noticed that the cat was depressed, anorexic, and ataxic. An hour later the owner took the cat to the veterinarian, where the cat was observed to have pallor, was tachypneic, and was hypothermic with a temperature recorded as 37.5 degrees Fahrenheit; a chemistry profile was done and the results were expected the next day. Later that morning the day the owner contacted the company to obtain help; the call was disconnected before the owner could be transferred to the Animal Product Safety Service (APSS), so an APSS veterinarian called the owner back to discuss the case. The APSS veterinarian also contacted the owner's regular veterinarian after speaking to the owner to discuss the case further. The APSS veterinarian stated that since the product only contained an insect growth regulator (IGR), clinical signs would not be anticipated. The APSS veterinarian recommended that the owner's regular veterinarian provide supportive care such as warming and possibly fluids and call back with questions.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation and that anemia was considered to have an unknown likelihood of causing the clinical situation. On September 20, 2013 an APSS technician called the owner's regular veterinarian to update the case. The owner's regular veterinarian stated that unknown supportive care was provided at an unspecified time and that on September 19, 2013 the cat had recovered from all of his symptoms except for depression, which was less severe; the owner decided to take the cat home since he had started eating again and was no longer ataxic.