Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0041

2. Registrant Information.

Registrant Reference Number: 150098422

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.

20-JUL-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

19-JUL-15

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. 31439      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Breakaway Flea And Tick Collar For Cats And Kittens

• Active Ingredient(s)
  • TETRACHLORVINPHOS

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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 July 6, 2015 the owner applied the collar onto the cat for prevention.

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

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• Skin
  • Symptom - Hair loss
  • Symptom - Erythema
  • Symptom - Dermatitis

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 July 12, 2015 the owner removed the collar. On July 19, 2015 the cat developed symptoms around the neck, which is the width of the collar. On July 20, 2015 a veterinary staff member called the Animal Product Safety Service (APSS), stating that the cat was not yet at the clinic (new patient, has not been evaluated by clinic yet- patient details unknown), but the owner wants the cat treated, but wants reimbursement from the company for veterinary expenses. The APSS veterinarian stated dermal irritation or contact hypersensitivity may occur as with any topical exposure. The APSS veterinarian also stated in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS veterinarian recommended a referral to the manufacturer (to discuss if treatment is covered by the manufacturer as they did not want to discuss treatment recommendations with the APSS), having the veterinarian call for information (if want to discuss treatment options), and calling back with questions.

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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

Clinic did not want to discuss treatment recommendations with APSS.