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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5002

2. Registrant Information.

Registrant Reference Number: 090088022

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.

05-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

30-JUL-09

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. 2724-504-270

Product Name: Bio Spot Spot On Flea and Tick Control for Cats 5 lbs and Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.804

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 July 30, 2009 the pet owner applied the product to the 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 Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

10

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Hiding
  • Skin
    • Symptom - Hair loss
  • Nervous and Muscular Systems
    • Symptom - Trembling
  • Renal System
    • Symptom - Urinary incontinence
  • Gastrointestinal System
    • Symptom - Weight loss
  • Nervous and Muscular Systems
    • Symptom - Depression
  • General
    • Symptom - Weakness
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Pale mucous membrane colour
    • Symptom - Hypothermia
    • 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 July 30, 2009 the cat was hiding. On August 4, 2009 the cat came out of hiding. The APSS veterinarian recommended that they have the veterinarian call for information once they arrive at the clinic. The regular veterinarian contacted the APSS that same morning. The APSS veterinarian recommended that the regular veterinarian perform a diagnostic evaluation, bathe the cat with liquid dish soap once the cat was stable, give methocarbamol, provide symptomatic and supportive care, offer nutritional support, and call back with questions.


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 and that signs were more likely related to the cat hiding and disappearing for 5 days. On the afternoon of August 5, 2009, the pet owner contacted the APSS. The pet owner stated that the veterinarian told her the cat was anemic because he had white mucous membranes and was hypothermic with a body temperature of 90 degrees Fahrenheit. The cat was discharged to the owner with unknown medication and instructions to return on August 6, 2009 for follow up. The cat died en route home on August 5, 2009. The owner declined necropsy.