Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0048

2. Registrant Information.

Registrant Reference Number: 110148264

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.

21-NOV-11

5. Location of incident.

Country: CANADA

Prov / State: NEWFOUNDLAND

6. Date incident was first observed.

18-NOV-11

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 Fleatrol 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 18, 2011 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

9.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Loss of voice
  • Specify - Dysphonia

• Gastrointestinal System
  • Symptom - Constipation
  • Specify - Absent Bowel Movements

• Renal System
  • Symptom - Anuria

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 16, 2011 the owner observed that the cat had pre-existing scabs on his tail. On November 18, 2011 the owner applied some olive oil on the cat's scabs at the same time as she placed the flea and tick collar on the cat. Shortly after the owner placed the flea and tick collar on the cat, the cat became dysphonic. About an hour later, the owner removed the flea and tick collar; an hour later she placed the collar back on the cat. On the morning of November 20, 2011, the owner observed that the cat had not had any bowel movements and was not urinating. However, the owner noticed that the cat's pre-existing scab was milder at that time. On November 21, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the ingredients in the collar have a wide margin of safety and that significant clinical signs would not be expected. The APSS veterinarian also stated that dermal reactions could be seen near the collar location in sensitive individuals, but a change in voice would not be expected. The APSS assistant recommended that the owner consult with a veterinarian about flea area treatment and discuss any questions about which Zodiac spot on product to use with the manufacturer.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because no significant signs were expected. Therefore, the outcome of this case is unknown.