Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0849

2. Registrant Information.

Registrant Reference Number: 100135735

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.

18-OCT-10

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

17-OCT-10

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 October 2, 2010 the owner sprayed the cat with an Adams mist and also bathed the cat with an Adams shampoo to treat a flea infestation. That same day, the owner also applied the product. On October 4, 2010 the owner removed the collar, sprayed the cat again and re-bathed the cat with the shampoo, then reapplied the collar. Again on October 15, 2010 the owner re-bathed the cat with the shampoo and sprayed the cat with the mist.

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

Male

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

2

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Rectal hemorrhage

• Renal System
  • Symptom - Inappropriate urination

• Respiratory System
  • Symptom - Dyspnea

• General
  • Symptom - Vocalizing

• Blood
  • Symptom - Anemia

• 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 October 17, 2010 the owner noticed the cat had some rectal bleeding. The next day, October 18, the owner found the cat with additional symptoms, so the owner took the cat to the veterinarian, where she was told the cat was anemic. The cat died shortly later. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated when used as per label directions, significant signs are not expected. The APSS veterinarian recommended calling the manufacturer to discuss product efficacy and calling the veterinarian regarding flea control and preventative for the other household pets.

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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 substances were not considered to be related to causing the clinical situation. Per APSS, all signs were not consistent with anemia so an underlying condition was suspected.