Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5712

2. Registrant Information.

Registrant Reference Number: 110107097

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.

19-AUG-11

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

18-AUG-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. 2724-497-270

Product Name: Bio Spot Spot On Flea and Tick Control For Dogs Medium Size Dogs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3 %
  • PERMETHRIN
    • Guarantee/concentration 45 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.068

Units: oz (fl) / oz (liquide)

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 August 18, 2011 the owner applied the product to her dog.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Australian Cattle Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

35.0

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 - Lethargy

• Respiratory System
  • Symptom - Panting

• Gastrointestinal System
  • Symptom - Drooling

• Eye
  • Symptom - Conjunctivitis

• Nervous and Muscular Systems
  • Symptom - Semi comatose

• 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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On August 18, 2011 the owner noticed the dog was lethargic, panting, and drooling. On the morning of August 19, 2011 the owner took the dog to the veterinarian, where he was bathed with liquid dish washing detergent (LDWD) and fluid therapy was provided. At this time, the dog was no longer panting, but he did have conjunctivitis and was in a semi-comatose state. The regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24 to 72 hours to resolve fully. The APSS veterinarian recommended that the regular veterinarian perform a diagnostic evaluation on the dog with labs and radiographs, continue treatment, provide symptomatic and supportive care, and call 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

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On August 22, 2011 an APSS technician contacted the regular veterinarian to update the case. The regular veterinarian stated that by the afternoon of August 19, 2011, the dog was no longer drooling, and the owner elected to take the dog home that evening. The regular veterinarian also reported that the owner had called back on August 20, 2011 to state that the dog had died that morning. A necropsy was not available because the body had already been buried.