Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5610

2. Registrant Information.

Registrant Reference Number: 140114380

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.

09-SEP-14

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH CAROLINA

6. Date incident was first observed.

09-SEP-14

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. 1021-2684-89459

Product Name: Adams Flea and Tick Dip for Dogs and Cats

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 3 %
  • PYRETHRINS
    • Guarantee/concentration .3 %

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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: 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 September 9, 2014 the owner inappropriately applied the product directly to the back of the dog's neck, it was not diluted as per label directions. The kitten and dog were playing and the kitten was biting the dog's neck.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

2.0

lbs

8. Route(s) of exposure

Oral

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 - Weakness

• Nervous and Muscular Systems
  • Symptom - Difficulty walking
  • Symptom - Disorientation
  • Symptom - Ataxia

• Eye
  • Symptom - Other
  • Specify - Closed Eyes

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On September 9, 2014 the kitten became symptomatic. The owner called the Animal Product Safety Service (APSS), but treatment recommendations were not provided given the signs, the option of taking the kitten to the veterinarian and then calling back to complete the consult were made. The call was disconnected prior to formal recommendations after speaking with the APSS veterinarian.

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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 APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 11, 2014 the APSS assistant called the owner to follow up. The owner stated she took the kitten to the veterinary clinic where they gave activated charcoal, fluid therapy, then discharged the kitten from the hospital. On September 10, 2014 the kitten died. A necropsy was not available.