Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7299

2. Registrant Information.

Registrant Reference Number: 130144730

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.

16-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

15-OCT-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 October 11, 2013 the owner placed the flea and tick collar on 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

Medical Professional

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 )

7.0

7. Weight (provide a range if necessary )

6.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

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

• Nervous and Muscular Systems
  • Symptom - Collapse
  • Symptom - Unresponsive

• Eye
  • Symptom - Pupil dilation
  • Symptom - Nystagmus

• Nervous and Muscular Systems
  • Symptom - Paralysis
  • Specify - Hind Limb Paresis

• Blood
  • Symptom - Hyperglycemia

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

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

The cat had lost 1 kilogram (kg) of weight since June 2013. On July 15, 2013 the owner noticed that the cat had polydipsia and polyuria. The flea and tick collar was placed on the cat on October 11, 2013. On the evening of October 15, 2013 the owner noticed that the cat was vomiting. On the morning of October 16, 2013 the owner noticed that the cat had collapsed. The owner immediately took the cat to the veterinarian, where it was observed that he was unresponsive, had mydriasis, had nystagmus, had hind limb paresis, and had hyperglycemia with serum glucose measured at 17.0 milligrams per deciliter (mg/dL). The owner's regular veterinarian placed an intravenous (IV) catheter, provided fluid therapy, gave the cat oxygen, bathed the cat, and measured the cat's blood glucose level. Later that day the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that within 4 hours of applying the flea and tick collar vomiting, drooling, and diarrhea might be a risk. The APSS veterinarian recommended that the owner's regular veterinarian perform a diagnostic evaluation and provide symptomatic care to the cat.

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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 not considered to be related to causing the clinical situation.