Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0848

2. Registrant Information.

Registrant Reference Number: 100134951

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.

17-OCT-10

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

16-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. 2724-796-270

Product Name: Adams Flea and Tick Spot On E30 for Extra Large Dogs 81-150 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 30 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 5 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

9

Units: mL

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 16, 2010 the owner applied the product onto the geriatric dog with medical issues.

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

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

53

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Respiratory System
  • Symptom - Heavy breathing

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Collapse

• Skin
  • Symptom - Erythema

• General
  • Symptom - Weakness
  • 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?

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 October 16, 2010 the dog developed symptoms. On October 17, 2010 the owner took the dog to the veterinarian, where they bathed the dog with chlorhexidine scrub and performed an electrocardiogram. The attending veterinarian then contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended bathing the dog with liquid dish washing detergent, monitoring the dog at the veterinary facility, performing a diagnostic evaluation, providing symptomatic and supportive care, applying a cold compress and Vitamin E, and calling back with questions.

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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

On October 21, 2010 an APSS assistant called the attending veterinarian to follow up the case. The attending veterinarian stated that they bathed the dog and gave the dog an injection of dexamethasone. The attending veterinarian further stated that the owner had refused all other treatment and took the dog home on October 17 and the dog died later that night. This product was not used according to label directions: consult a veterinarian before using on a geriatric pet.