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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5003

2. Registrant Information.

Registrant Reference Number: 090090592

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.

11-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

11-AUG-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 and Kittens Under 5 Lb

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

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

Product Name: Adams Spot On Flea and Tick Control for Large Dogs Over 60 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 August 11, 2009 the pet owner applied the Bio Spot Spot On Flea and Tick Control for Cats and Kittens Under 5 Lbs to her cat. On that same day, the pet owner applied the Adams Spot On Flea and Tick Control for Dogs Over 60 Lbs to her dogs. The owner suspects that the cat was exposed to the dog product via relay exposure.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Seizure
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

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

The APSS veterinarian stated that the Bio Spot Spot On Flea and Tick Control for Cats and Kittens Under 5 Lbs would not be expected to cause the signs the cat was displaying. Signs can develop with relay exposure if a permethrin product is used on the dog(s) in the house. The cat's signs were consistent with an exposure to permethrin. She recommended that the pet owner take the cat to the veterinarian immediately, have the veterinarian call for information, and call back with questions. Later that same afternoon, the pet owner contacted the APSS to report that the cat had developed seizures and died on the way to the veterinarian. On August 12, 2009 the APSS veterinarian recommended a necropsy.


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 Bio Spot Spot On Flea and Tick Control for Cats and Kittens Under 5 Lbs was considered to have a doubtful likelihood of causing the clinical situation. The APSS veterinarian stated that the Adams Spot On Flea and Tick Control for Large Dogs Over 60 Lbs was considered to have a high likelihood of causing the clinical situation. On August 12, 2009 an APSS technician spoke to the pet owner to discuss necropsy and permethrin hair testing. The APSS technician stated that a necropsy and hair testing were no longer options because the body had not been preserved and accurate results likely would not be obtained. the product was not used according to label directions: cats that actively groom or engage in close physical activity with recently treated dogs may be at risk of serious harmful effects.