Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6235

2. Registrant Information.

Registrant Reference Number: 130161845

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.

22-NOV-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

22-NOV-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)

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PMRA Registration No. 19210      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Breakaway Flea and Tick Collar For Cats

• Active Ingredient(s)
  • PROPOXUR

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 November 22, 2013 the owner placed the collar on the kitten to treat for fleas; the owner noticed that the kitten was able to bite the collar and was licking at the area, so an oral exposure was suspected. Unknown if collar was fitted properly.

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 Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

2.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

• General
  • Symptom - Hyperactivity

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Disorientation
  • Symptom - Stiffness

• General
  • Symptom - Licking

• Gastrointestinal System
  • Symptom - Inappropriate defecation

• Nervous and Muscular Systems
  • Symptom - Shaking
  • Symptom - Depression

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 November 22, 2013 the owner noticed that the kitten was had an isolated episode of drooling and hyperactivity (running and jumping all around the room). At the time those signs began, the owner also noticed that the kitten was ataxic (walking funny), disoriented, experiencing intermittent stiffness of her back legs (and crawling when her back legs were stiff), and was licking at the roof of her mouth, almost appearing as if meowing, but no sound came out except for a weird breathing noise. Later that evening the owner noticed that the kitten inappropriately defecated all over the couch. The owner immediately contacted the Animal Product Safety Service (APSS) to obtain help. During the consultation the owner observed that the kitten was shaking and also (later in the consultation) that the kitten was depressed, appearing slow and "dopey" and having an almost blank stare; the kitten was barely responsive and would just keep licking at her paw and missing the toy the owner tried to show her. The APSS assistant recommended that the owner take the kitten to the veterinarian and have the veterinarian call for information, but the owner was reluctant to do so. The APSS assistant also recommended that the owner bath the kitten with a liquid dish washing detergent (LDWD); provide oral decontamination by using a thin, wet washcloth placed over the pinky finger to wipe the kitten's mouth; give the kitten a small meal of tuna juice, salmon juice, or something more substantial to eat; minimize sensory stimuli; restrict the kitten's activity; confine the kitten; and call back with questions.

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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 considered to have a medium likelihood of causing the clinical situation. An attempt to update the case was unsuccessful; therefore, the outcome is unknown. Unknown if collar fitted properly if cat was able to reach collar.