Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0116

2. Registrant Information.

Registrant Reference Number: 1-40242833

Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL

Address: 100 STONE ROAD WEST, SUITE 111

City: GUELPH

Prov / State: ON

Country: CANADA

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

14-APR-15

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

10-APR-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.       PMRA Submission No.       EPA Registration No. 2724-734-2596

Product Name: UltraGuard Ear Mite Treatment for Cats

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .5 %
  • PYRETHRINS
    • Guarantee/concentration .05 %

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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: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Caller states he applied the product to his cat. Cat was a rescue cat and not in perfect health. Veterinarian not contacted before product use.

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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic short hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

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

The cat's owner began using the product 'awhile back'. At some point after treatment, the cat became anorexic. Miss Kitty passed away on 4/21/15. Miss Kitty was rescued by the owner and the caller less than a year ago and was not in perfect health to begin with. He had told the owner that using this product without speaking with the veterinarian was not a good idea in the first place.

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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 caller asked is this product appropriate to use without first speaking with a veterinarian? The product is intended to be used at home on pets that are otherwise healthy and over the age of 12 weeks. It is not intended to be applied to geriatric patients. Any pets who are geriatric, young, in poor health, etc should not have OTC products applied without the advice of a DVM. Death would not be expected. The concentration of pyrethrins is very low. With a concentration this low, there is really no potential for dermal absorption, thus little to no possibility of a systemic toxicity. If the cat had an upset stomach, this can cause anorexia. However, the anorexia is not something that would be expected to persist for more than a day or so. It is more likely than not that the cat had an underlying issue, or was simply dying of old age.