Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1457

2. Registrant Information.

Registrant Reference Number: 110023651

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.

25-FEB-11

5. Location of incident.

Country: UNITED STATES

Prov / State: WISCONSIN

6. Date incident was first observed.

13-FEB-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.       PMRA Submission No.       EPA Registration No. 2724-491-270

Product Name: Adams Plus Breakaway Flea and Tick Collar For Cats and Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 2.1 %
  • PROPOXUR
    • Guarantee/concentration 10 %

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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 February 13, 2011, the owner placed the collar on her cat.

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 Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.5833

7. Weight (provide a range if necessary )

3.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Vocalizing

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Hyperactivity
  • Symptom - Abnormal behaviour
  • Specify - Fly Biting

• Eye
  • Symptom - Miosis

• 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

On February 13, 2011, the owner noticed her cat was symptomatic. Shortly after, the cat died. On February 25, 2011, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated the main concern would be for gastrointestinal (GI) upset, a taste reaction from licking the collar, dermal irritation from contact, or possibly a hiding response from the stress of having the collar on or possibly because of the smell. The APSS veterinarian also stated she wouldn't really expect to see organophosphate (OG) problems (systemic) from this type of situation though this isn't really what is expected from the concentration of the substance in the product. The APSS veterinarian recommended a necropsy and to call back with questions, but found out that the cat had already been buried and would not be available for a necropsy.

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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.