Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5608

2. Registrant Information.

Registrant Reference Number: 140113729

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-SEP-14

5. Location of incident.

Country: UNITED STATES

Prov / State: WEST VIRGINIA

6. Date incident was first observed.

07-SEP-14

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-404

Product Name: Zodiac Fleatrol Flea and Tick Spray for Dogs Cats Puppies Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .27 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .62 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .37 %
  • PYRETHRINS
    • Guarantee/concentration .2 %

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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 September 7, 2014 the owner sprayed the product onto the cat.

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

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Paralysis
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Trembling
  • Symptom - Semi comatose

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

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 September 7, 2014 the owner noticed the cat was hypersalivating. Later that day, when the owner's bathed the cat with liquid dish washing detergent (LDWD) the cat seemed to have paralysis (unable to move anything but his head when getting him out of the carrier and he was limp during the bath). A short time later, the owner noticed the cat was trembling. Later that evening, the owner contacted the Animal Product Safety Service (APSS) and while on the phone the cat had a seizure (anytime he moves, he looks like he's seizuring). The APSS veterinarian stated the risk if for a taste reaction and dermal irritation or parethesia-like reaction. The APSS veterinarian also stated seizures or paralysis are not expected. The APSS veterinarian further stated could see reluctance to move due to skin tingling sensation, but true paralysis is not expected. The APSS technician recommended taking the cat to the veterinarian (owner stated cannot afford to take to the vet tonight), minimizing sensory stimuli, giving karo syrup (rub some on his gums), taking the cat to the veterinarian (tomorrow am if condition is not improved), and have the veterinarian call for information.

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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. On September 8, 2014 the owner called the APSS to update the case. On September 8, 2014 the cat became semi comatose, so she took the cat to the veterinary clinic, where fluid therapy was given. The attending veterinarian called the APSS. The APSS technician recommended symptomatic and supportive care and blood glucose. On September 10, 2014 the owner called the APSS back to state that the cat just died at the clinic. A necropsy was recommended, but was not available.