Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5167

2. Registrant Information.

Registrant Reference Number: 160051356

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.

13-APR-16

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

09-APR-16

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. 2596-139-89459

Product Name: Adams Plus Flea And Tick Collar For Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 1.02 %
  • TETRACHLORVINPHOS
    • Guarantee/concentration 14.55 %

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7. b) Type of formulation.

Other (specify)

Collar

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 April 8, 2016 the owner put the collar on the cat to treat for ticks.

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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hiding

• Nervous and Muscular Systems
  • Symptom - Disorientation

• General
  • Symptom - Weakness
  • Symptom - Other
  • Specify - Wound

• Respiratory System
  • Symptom - Laboured breathing

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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

On April 9, 2016 the cat started hiding (went missing over the weekend, which is unusual). On April 11, 2016 the cat came home and presented with disorientation, weakness, and a wound (on her back, sections of skin missing). The owner removed the collar after wondering if the collar caused the cat to be disoriented and she fell out of a tree or something. On April 12, 2016 the cat developed labored breathing. Later that morning the owner found the cat dead. On April 13, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the risk is for mild dermal sensitivity. The APSS technician recommended a necropsy, which was not possible even though the cat had not been buried, as the cat's body was still in the owner's bathroom.

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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 not considered to be related to causing the clinical situation.