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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2008-3378

2. Registrant Information.

Registrant Reference Number: 080040850

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.

21-APR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

20-APR-08

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-497-270

Product Name: Bio Spot Spot On Flea And Tick Control For Dogs 16 to 30 Lbs

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 18, 2008, the owner applied one drop of the product to her dog as a preventative measure.

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

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Hyperthermia
    • Symptom - Death
  • Respiratory System
    • Symptom - Pneumonia
    • Specify - severe acute necrosuppurative bronchopneumonia with intralestional bacteria
    • Symptom - Pulmonary edema
    • Specify - severe pulmunary edema
    • Symptom - Pneumonia
    • Specify - bronchopneumonia

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?

3

Day(s) / Jour(s)

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

At the clinic the animal was diagnosed with hyperthermia and was provided symptomatic care. On April 21, 2008, the APSS veterinarian stated that seizures would not be expected from product usage. The APSS veterinarian recommended the attending veterinarian rule out other conditions that may be causing the animal's signs. The animal died on April 23, 2008. The necropsy results are: The results of the necropsy suggest pneumonia, likely secondary to aspiration. The brain histopathology was normal.


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 doubted that this substance was related to causing the clinical situation.